SABA GROVES, MD, MSC

MANAGER PHARMACOVIGILANCE

ad1ezv@r.postjobfree.com/919-***-****

APEX, NC, USA

CANDIDATE PROFILE

Person is a highly motivated and customer-focused Manager within Project Management, offering an impressive 14 years of expertise in the drug safety, clinical research, and pharmaceutical industries. With a specialized focus on pharmacovigilance, Saba brings more than eight years of professional drug-safety experience, including extensive involvement in developing global teams of PV professionals to support a wide array of PV activities. Her competencies encompass ICSR management, aggregate safety report preparation, literature surveillance, PVA management, safety science coordination, and regulatory reporting. Her professional journey also includes comprehensive experience in all facets of PV project management, spanning from contract development through start-up, maintenance, and closeout phases. She bears the responsibility for financial management, resource allocation, compliance monitoring, risk and issue mitigation, and the successful overall delivery of projects. Additionally, she boasts a strong skill set in PV regulations, process development, quality assurance, compliance monitoring, safety database activities, people management, and process improvement.

Among her key achievements are responsibilities related to supporting pharmaceutical companies with oversight activities, such as the development of Key Performance Indicators (KPIs), ensuring regulatory compliance, managing PVA and SDEA compliance, preparing for audits and inspections, and handling various project management tasks.

EDUCATION

Rajasthan Vidyapeeth University, Udaipur, Rajasthan, India Masters in microbiology, January 2010

Mahatma Gandhi Mission Medical College, Aurangabad, Maharashtra, India 1

Medical Doctor, January 2001

Maulana Azad College, Aurangabad, Maharashtra, India High School Diploma, January 1995

LICENSES & CERTIFICATES

Barnett GCP Certificate of Completion, 2017, 2015

Coding with MedDra training, 2018, 2016

Safety Data Analysis Training, 2016

IATA Certified (SafTPakInc.), 2014

CSSRS Certificate (RFMH), 2014

Collaborative Institutional Training Initiative (CITI), 2013

Investigator Site Personnel ICH GCP Training Certificate, 2013

Certification in “Protecting Human Research Participants”, 2013

Life and Health Insurance NC Licensed Producer, 2013 PROFESSIONAL EXPERIENCE

Thermo Fisher Scientific /PPD, Morrisville, NC, USA

Manager Pharmacovigilance, April 2022-July 2023

Ensure assigned projects/teams have sufficient resources.

Provide teams direction on assigned projects and tasks.

Proactively liaise with the Project Manager and the client to ensure optimal performance and utilization of the PVG team.

Manage the Safety Specialists and coordinate the Serious Adverse Event

(SAE) processes for all PVG projects.

Interact with the PVG physicians and administrative staff, the Clinical Project Teams and Data Management to ensure company SOPs and regulatory guidelines are followed.

Prepare and present at audits, business development, client and PPD team meetings.

Prepare proposals for PVG activities.

Ensure and oversee the training of PVG personnel.

Input to the preparation of PVG WPDs and SOPs

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Coordinate safety database activities for specific projects.

Participate in departmental initiatives and task forces for process improvement including aligning with stakeholders, setting objectives, developing, and tracking project plan, timelines, and milestones, tracking deliverables, resolving key issues and achieving desired outcomes and overall department management.

Ensure team compliance with PPD or Client SOP and WPDs on assigned studies.

Ensure regulatory compliance is maintained on all assigned projects within the team.

Escalate compliance issues with senior management and client to resolve issue.

Track, manage and maintain responsibility for the PVG budgets for assigned projects within the team.

Participate in Executive Review meetings to communicate progress of PVG quality, budgetary or operational issues.

Assist in new contract preparation and contract modification.

Principal safety specialist (project lead), March 2021-April 2022

Supervision over a Pharmacovigilance (PVG) team/group where majority of the time is utilized ensuring project work is delivered on time, following appropriate standards, and staying within budget.

Perform project and budget management for multiple projects.

Serve as a mentor to PVG staff for budget management, Serious Adverse Event (SAE) processing, SAE database, regulatory reporting, narrative generation, and quality control activities.

Provide department training for pharmacovigilance procedures/processes.

Assist in the preparation and revision of department SOP and WPDs.

Prepare for and attend audits, kick off and Investigator meetings and bid defenses.

Work with Project Teams, the Client Company, regulatory bodies, and Investigators regarding SAE activities as needed.

Provide project specific safety training to PPD Clinical on assigned projects.

Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into PPD-owned or client provided adverse event database, review of entered cases for quality, consistency, and accuracy, and follow up with report and/or associated HCP, tracking of reports, and reporting activities.

Code adverse event terms and write narratives according to client convention.

Assist with preparation and review of regulatory reports.

Work with cross functional teams and/or prepare aggregate safety reports including DSUR, PADER, PBRER and SUSAR line listings.

Signal management and analysis of safety data from PM and CT. Perform signal management activities (Qualitative signal activities) including signal detection, validation, and evaluation of safety signal reports on a monthly/quarterly and semi-annual basis. Also perform review of medical/scientific literature for signal detection activities and aggregate reporting.

Provide training, mentoring and work direct to more junior level staff, and quality review of data including adverse event reports. 3

Maintain knowledge and understanding of PPD and client-provided SOPs and current local and global regulations.

Assist with writing and review of PVG procedural documents in accordance with PPD and regulatory requirements.

Resolve complex program through in-depth evaluation of various factors.

Effectively communicate with managers, team members, client contacts and adverse event reporters; often serve as program lead to disseminate information to team members.

Assist the program management team with day-to day operational needs.

Senior Safety Specialist (project lead), May 2018-March 2021

Performed day-to-day adverse event reporting and subsequent Pharmacovigilance (PVG) activities in accordance with Good Clinical Practices

(GCPs), Standard Operating Procedures (SOPS) and Working Practice Documents (WPDs), current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues.

Organized and managed serious adverse event (SAE) processes and database activities.

Coordinates and performs adverse event data entry, narrative writing, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities.

Ensured any expedited safety reports were notified to applicable Regulatory Authorities, Ethics Committees and Principal Investigators within regulatory timelines.

Reviewed compliance of expedited safety reporting on assigned projects and escalated problems or issues to PVG Manager.

Coordinated and managed a global study.

Reviewed cases entered for quality, consistency, and accuracy, including review of peer reports.

Effectively communicated with team members, client contacts and adverse event reporters.

Developed an understanding of budgets and forecasts for assigned projects.

Effectively interfaced with project teams, Client Company, and Investigators regarding safety activities from project start-up through database lock.

Provided mentoring of Safety Specialists and new employees; in addition to, new procedures or procedures that require review.

Assisted in composing and preparing departmental and project-specific processes and procedures.

Prepared for and attended audits, kick-off meetings and investigator meetings.

Ashfield Pharmacovigilance, Morrisville, NC, USA

Case Manager II, June 2017-May 2018

Triaged, reviewed and processed operational data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle safety databases (Argus), MedDRA coding, writing narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, and prepare material for submission.

Tracked operational metrics.

Leaded the team and provided training and mentoring new staff, evaluation, 4

and feedback.

Actively communicated with manager upon identification of issues and proposing solutions, providing technical support, monthly metrics and out of scope work challenges/issues and successes.

Iqvia (Quintiles), Raleigh, NC, USA

Safety Operations Specialist, Oct 2015-June 2017

Reviewed data entry for tracking in safety database.

Coded relevant medical terminology.

Wrote descriptive narratives.

Generated queries pertinent to cases.

Assisted with reconciliation, drive case closure, coordinate translations and ensure reports were sent to the customers within assigned deadlines.

Ensured that all safety reports received from any source (Clinical trials end post-marketing), for assigned products and studies, were processed, and report it according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures.

Liaised withe other IQVIA hubs to ensure to appropriate cross reporting.

Participated in and conducted team and project-specific meetings and trainings.

Established Quality Assurance / Quality Control procedures to ensure quality of processed cases met required targets, were consistent and accurate with source documents and compliant with applicable procedures/guidelines.

Participated in client audit and support health authority inspections. Iqvia (Quintiles), Raleigh, NC, USA

Global Clinical Trials assistant, Apr 2014-Oct 2015

Responsibilities included independently monitoring site on-site, review of CRF’s, collection of site source data, completion of site visit notes and collection of regulatory documentation.

Monitoring of clinical trials, assured adherence to Good Clinical Practice, Investigator integrity and compliance with all study procedures.

Maintain eTMF by reviewing, filing, scanning, and uploading documents in accordance with GCP. Collaborates with the Lead Clinical Research Associate(s) to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics.

Managing activities including remote and on-site monitoring for the following visits: Monitoring visits, and Close-out visits. Proactively identifying solutions when issues arose. Managing key study parameters including shipping and return of IP, site supplies, IRB submissions, data collection, etc. Assist in designing study documents including, case report forms, site study procedure manuals and project tools, monitoring plans, tracking tools, and informed consent forms. Verifies trial product storage meets protocol and Standard Operating Procedures requirements.

Maintaining frequent contact and work effectively with investigators and coordinators.

Reviewing and resolving discrepancies in clinical data with clinical sites.

Acted as a central contact for the clinical team for designated project communications, correspondence, and associated documentation. 5

Wake Research Associates, llC, Raleigh, NC, USA

Research Coordinator, Oct 2013-Apr 2014

Coordinated clinical trials including Carolina Phase 1.

Assisted with all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files.

Assisted with Human subject’s submissions.

Mariam Clinic, Raleigh, NC, USA

Patient Intake Coordinator, Feb 2011-Sep 2013

Assisted healthcare providers with patient care. Performed patient intake, took medical histories, vitals, phlebotomy, electrocardiograms (EKGs) and assisted in examinations and procedures.

Dr. Jignasa Patel clinic, New Jersey, USA

Clinical assistant, Apr 2008-Jan 2011

Duties included taking medical history, recording vital signs of the patient, answering telephones, updating and filing patients’ medical records, coordinate drug orders with the pharmacist, laboratory sampling and processing, and regulatory documentation.

Renal Research Institute, New York City, USA

Research Coordinator and Sub-Investigator, Jan 2007-Mar 2008

Conducted and guided physician in the management of research protocol requirements.

Interacted with study patients, including consenting and executing study visit.

Assisted the investigator in the performance of research procedures.

Provided clinical expertise in conducting patient study visits in accordance with the study protocol.

Timely completion of all clinical study visits procedures and documentation while working with data management to ensure rapid resolution.

Effective Sponsor/CRO communication.

Assisted with site start-up/closure activities, perform drug accountability, temperature log maintenance.

Notification and communication with Physician and site personnel of patient and/or Sponsor visit requirements and patient medical conditions.

IRB Presentations

Participated in clinical meetings with clinical management.

Maintained ongoing communication with clinical and enrollment teams to ensure rapid and timely patient enrollment.

Seema Dental College and Hospital, Rishikesh, India

Diener, Jan 2006- Dec 2007

Department of Pathology and Microbiology-Assist with training dental students, being helpful and supportive in their teaching. VM Medical College and Safdarjung Hospital, New Delhi, India

Physician, Jan 2002- Jan 2003

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Managed emergency patients and admitted patients.

Monitored patients’ conditions and progress and reevaluate treatments as necessary.

Collected, recorded, and maintained patient information, such as medical history, reports, and examination results.

Participated in advanced and basic life support training programs.

Coordinated work with nurses, social workers, rehabilitation therapists, pharmacists, psychologists, and other health care providers.

Responsible for co-ordinations & communication between patients, staff, and consultant.

Quality exposure in handling administration functions in hospital thereby attaining high patient satisfaction.

Trained residents, medical students, and other health care professionals. Awadh Institute of Lab Technology, New Delhi, India

Physician, Jan 2002-Jan 2003

Guest Lectures in Anatomy and Physiology.

Clinic, India

General physician, Jan 2001-Dec 2001

Managed general outpatients.

Conducting regular patient check-ups.

Diagnosing any ailments.

Prescribing medication.

Providing advice to people on staying healthy.

Referring patients to specialists and consultants in hospital departments. VM Medical college and Safdarjung Hospital

Medical Doctor, Jan 2000-Dec 2000

Rotating Internship – General Medicine, General Surgery, Preventative Social Medicine.

Reproductive Health, Emergency Medicine, Ophthalmology, Otorhinolaryngology, Pediatrics

PUBLICATIONS AND PRESENTATIONS

Publications:

Textbook of Medical Parasitology – [ISBN: 81-89581-13-9]

Textbook Practical Pathology & Microbiology – [ISBN 10:81-89581-05/ISBN 13:978**********]

Essential Parasitology – Includes recent advances [ISBN: 818-***-****]

Dialysis Times – Article, “Overview of Infected Hemodialysis Catheter” (October 2007.vol 11, No 10)

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Dialysis Times – Article, “Prevention of depression in Hemodialysis patients”

Dialysis Times – Article, “Unintentional Noncompliance to Dietary Phosphorus Restrictions”

Presentations:

IRB Presentations:

July 2007: Dysfunctional Hemodialysis Catheter

August 2007: Growth hormone in Adult Patients on Chronic Hemodialysis Patients

December 2007: A phase 3, Randomized, Active-controlled, Open label, The Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anemia. Hemodialysis Patients Previously Treated with Epoetin Alfa. LANGUAGES

Native Tongue: Hindi; Fluent: English and Urdu

POST MARKETING EXPERIENCE

Post-Marketing global projects in the psychiatric field (alcohol & opioid dependence & schizophrenia and oncology (metastatic pancreatic cancer and ovarian cancer)

THERAPEUTIC EXPERIENCE AND EXPERTISE

Neuroscience: Multiple Sclerosis, Major Depressive Disorder (MDD)

Other Areas of Expertise: E.g., immunotherapy, CAR-T, rare disease, healthy volunteers, pediatrics

CLINICAL TRIAL EXPERIENCE

Circulatory: Heart failure, Angina pectoris, Cardiac Dysrhythmias, Hypertension/Hypotension, MI, TIA, Venous/Arterial issues 8

Dermatology: Atopic Dermatitis, Acne, Psoriasis, Rosacea

Digestive System/Gastro-intestinal: Crohn’s Disease, Crohn’s disease, Gastritis, Bowel obstruction, Appendicitis, Diverticulitis, Constipation, Cystic fibrosis

Endocrine/Metabolic: Diabetes mellitus, Hyperglycemia/Hypoglycemia, Nutritional Diseases

Genitourinary: Contraception, Female Pelvic Inflammation, Endometriosis, Sexual desire disorder

Hematology: Coagulation defects, Anemia, Chronic Renal Anemia, White Blood Cell Diseases, Hemophilia, Lupus Erythematosus

Infections/Parasitic Disease: HIV, Hepatitis C, Methicillin-Resistant Staphylococcus Aureus (MRSA), Costridium difficile, Respiratory Syncytial Virus

(RSV), Cellulitis, Infectious diseases

Musculoskeletal: Osteoporosis, Arthritis, Rheumatoid Arthritis, Osteoarthritis, Muscular dystrophy, Fibromyalgia

Nervous System/Sense Organs/Mental Disorders: Alzheimer’s multiple sclerosis, Schizophrenia, Seizure Disorder, Anxiety, Drug Dependence, Alcohol Dependence, Chronic Pain, Insomnia, Mood disorder

Oncology: Colon cancer, Metastatic pancreatic cancer

Respiratory: Acute tonsillitis, Influenza, Cystic fibrosis, Respiratory Tract Infection

Immunology: Myasthenia Gravis

Palliative: End-of-life counselling, care, and management AUDIT EXPERIENCE

Investigator Site Audit

Database Audit

Vendor Audit

COMPUTER EXPERIENCE

MS Office (Word, MS Excel, MS PowerPoint, MS Outlook), EDC (MediDATA Rave, InForm), CTMS, eTMF, (Veeva Vault), ELVIS, EEL, STS, ARISg and ARGUS Safety 9

Database

RECOMMENDATIONS: September 15, 2023

Mason Yamashita (Vice President, Pharmacovigilance at Zenas BioPharmaVice President, Pharmacovigilance (PVG) at Zenas BioPharma) (CLIENT) Saba is a great PV manager. She managed my PV project on the CRO side for two global pivotal phase 3 studies. I depended on her comprehensive knowledge and leadership on many occasions. Saba is responsible, responsive, forward thinking, and a strong leader. She will always be my first choice for future PV projects.

Stephanie Howe (Associate Director PVG at Thermo Ficher) (MANAGER) Saba has extensive experience in Pharmacovigilance with demonstrated leadership skills in people and project management. She has led multiple PV projects from an operational and financial perspective. Saba has received praise from her direct reports and client contacts as a result of her diligence and commitment to driving efficiency and productivity. Saba is a pleasure to work with and would be an asset for any position which enables her to utilize her PV knowledge and experience.

Mohammed Ibrahim Ahmed (Manager PVG at Thermo Ficher) (COLLEGUE) Saba is a diligent, knowledgeable, and very efficient team manager. She has been instrumental in successfully driving multiple complex projects simultaneously. Her team building skills and client management abilities have resulted in keeping the clients satisfied along with her team being happy, which is a rare quality to have. Saba's expertise in the field of PV is commendable and her project & budget management abilities are top notch. I would highly recommend Saba for any management role within Pharmacovigilance domain especially with regards to SAE management & project delivery.

Heather King (Senior Manager PVG at Thermo Ficher) (COLLEGUE and Mentor) Saba maintains a good work ethic, a passionate, dedicated attitude and commitment to her employer and team. As a mentor and then peer, I have watched Saba grow initially as a safety specialist, PV lead and into management. Saba understands the importance of having others who can provide insights and perspectives that might differ from her own. She is willing to put the needs of others before her own personal gain and demonstrates a level of character that is rare and valuable for all employers.

Link below to see more:

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