Dr. Akansha Saxena

(MBBS, DNB -Diplomate of National Board)

(Senior Drug Safety Physician & Medical Reviewer, Pharmacovigilance)

ad3iko@r.postjobfree.com USA Connect: +1-908-***-****

https://www.linkedin.com/in/dr-akansha-saxena-2122205

Edison, New Jersey - 08820

PROFESSIONAL SUMMARY:

M.B.B.S. [Bachelor of Medicine & Surgery] and DNB- Diplomate National Board (Medical Microbiology and Virology) with 14+ years of total work experience as Lead Medical Reviewer, Safety Physician, Pharmacovigilance (ICSRs), Medical Writer, Clinical Microbiologist, Hospital Infection Control specialist, Laboratory Quality Manager, Resident Medical Officer at tertiary care Hospital and private practitioner (Family medicine). Over the years I have worked on a vast variety of prescribed products belonging to various therapeutic areas such as- Ophthalmology, Neurosciences (Parkinson’s, Alzheimer’s, Schizophrenia, ADHD and Narcolepsy), Oncology (solid tumors), Hematological malignancies; Rare disease (Rett syndrome, LG syndrome), Immunology, DMARDs, Bone modifying agents and Gene-therapy (SMA). My experience in pharmacovigilance space includes working with leading companies such as Amgen, JNJ, BMS, Astellas, Acadia and Novartis. Additionally, I have gained valuable clinical experience serving as a resident medical officer and managing a private medical practice.

Sound knowledge of medical assessment of ICSRs for seriousness, adverse event coding (MedDRA), listedness assessment, narrative, causality, provide company comments and raising relevant medical follow-up queries for a wide range of prescribed products belonging to different therapeutic areas.

Well versed with regulations related to prescribed products and medical devices and current with the regulatory requirements and expectations including EMA ICH GVP Modules, FDA IND and NDA reporting requirements and global risk management requirements.

Performed review of literature for citations relevant for PBRER/DSUR and identification of signals.

Implementing and promoting the use of quality processes in a consistent and efficient manner to meet regulatory and internal timelines and deliver according to industry best practices.

Retrospective review of cases reviewed by the team for measuring quality of deliverables, identifying error trends and training needs. As well as secondary level review of cases reviewed by primary medical reviewers for product sign offs.

Provide inputs/ advice/ feedback to Case processing team pertaining to medical judgment and medical queries.

Discuss and implement any updates for specific molecules, client conventions or based on regulatory requirements.

Workflow management of cases in medical review and to ensure completion of all cases within stipulated timelines based on regulatory and BP reporting requirements.

Experience in interacting with service providers, external business partners and stake holders exhibiting excellent teamwork and interpersonal skills.

WORK EXPERIENCE

Medical Reviewer, Drug Safety Physician

Acadia Pharmaceuticals Inc. USA & Astellas Pharma USA Inc. (Parexel International Corporation-Senior Drug Safety physician - 20 Dec 2021–Jan 2023

Novartis USA (Cognizant Technology Solutions- Lead Medical Reviewer, Novartis MR & CP -20 Dec 2020 - Dec 2021)

Amgen Inc USA, Johnson & Johnson USA (Sciformix Corporation -Safety Physician, Medical Affairs & Medical Safety Operations - Oct 2012 - May 2016)

BMS (Accenture Corporation - Medical Reviewer & Safety Physician Consultant/ Asst Manager - Sept 2011 - Nov 2011}

Quality Management, Infection control, Consultant Microbiologist

Noida Medical Centre Super Specialty Hospital Noida and VIMHANS Hospital, Delhi- Lab Quality Manager cum Consultant Microbiologist - Jan 2008 – Dec 2009

Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi- Diplomate National Board Training and Resident doctor - August 2004 – August 2007

Noida Medical Centre Super Specialty Hospital – Resident Medical Officer, Noida May 2004 - July 2004

Professional Education

Completed 3 years of training for DNB (Diplomate of National Board) in Medical Microbiology at Indraprastha Apollo Hospitals New Delhi, August 2007

MBBS [Bachelor of Medicine and Bachelor of Surgery], Government Sarojini Naidu Medical College AGRA) [Dr. B.R. Ambedkar University, Agra, UP INDIA], December 2002

Role & Responsibilities

December 2021- Jan 2023

Senior Safety Physician, Pharmacovigilance, PAREXEL International Corporation

Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products as well as devices and combination products.

Ongoing safety surveillance and signal detection and analysis activities.

Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety.

Provide medical input in all required safety reports, such as –but not limited to – PBRERs, PSURs, Clinical Expert Statement, Investigator notification letters.

Review all documents or complex datasets assigned for scientifically relevant issues including drug safety.

Function as Pharmacovigilance representative/safety leader/senior technical lead on the projects, in Proposal Development Team and/or client meetings

Provide medical advice and support for the safety component of feasibility studies.

Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products.

Support of Medical Directors as required.

Support of the QPPV

Provide medical monitoring for assigned projects.

Review all documents assigned for scientifically/medically relevant issues including drug safety.

Function as medical representative/technical lead/senior technical lead on the projects, in Proposal Development Team and/or client meetings

Provide medical or scientific advice pertaining to publication strategy and review of documents.

Provide support for DMC and CEC management.

Medical Review of Literature Reports including epidemiological background research, Company sponsored Clinical trial reports, Study protocols, Clinical trial (Serious) Adverse Event Reports, Study protocols, Post marketing and Spontaneous (Serious) Adverse Event Reports.

Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks.

Authoring of safety sections of PBRERs/ PSURs, including benefit risk assessment, of PSURs, Clinical Expert Statements and other documents as required; general PSUR support.

Provide support in preparation of Periodic Safety Update Reports (PSURs)/DSUR (Development Safety update Report)

Review and sign off technical documents written by PAREXEL with respect to medically relevant matters with particular attention to those relating to drug safety- SOPs, Wis, Medical Handbooks

Accommodate Pharmacovigilance timelines through flexible approach to working hours.

Provide medical guidance to Safety Staff during the case processing cycle.

Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).

Provide medical input into Pharmacovigilance workflows and projects as required.

Provide medical safety expertise and training to other PAREXEL personnel, as required.

Medical monitoring – answering day to day medical and scientific questions, provide daily medical support to PAREXEL staff or site (investigator/study coordinator)

Review and sign off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness.

Provide reports to European Regulatory Authorities, FDA or other regulatory agencies; provide sponsors with periodic experience reports summarizing adverse events as required by the sponsor or authorities.

Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)

Provide medical review of complex advertising and promotional materials and non-promotional materials and ensuring accordance with established policies and practice standards, including regulatory guidelines.

Review and sign off Data Management listings of safety data, establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities. Review of Device and Combination products.

Participate in Proposal Development Teams (PDTs) for client bid meetings.

Provide support for marketing activities as requested.

Maintain up-to-date knowledge of therapeutic area expertise by attending Professional Society Meetings.

Keep current with professional and Pharmacovigilance regulations and knowledge.

Role & Responsibilities

December 2020- December 2021

Lead Medical Reviewer, Senior Safety Physician, Pharmacovigilance, Cognizant Technologies Solutions

Planning, co-ordination and completion of Medical Review activities and case analyses within specified timelines and adhering to quality parameters.

Ensure adherence to Cognizant and Client SOPs, Quality Management Plan, Project SLAs and KPIs,

Drive and participate in innovation and process improvement initiatives.

Liaise with Client/ Vendor POCs as required.

Participate in internal, client or regulatory audits and assist in timely closure of findings, as applicable.

Ensure that the delivery of medical services meet or exceed Service Level Agreements (SLAs).

Mentoring and coaching for new joiners in the Medical Review team.

Establish an excellent working relationship with the client medical team including managers/leads.

Perform retrospective review of cases reviewed for measuring quality of deliverables, identifying error trends, training needs and areas of improvement.

Manage day to day operations of the assigned medical review team including leaves, resource allocation and workload in close collaboration with supervisor.

Undertake primary/secondary medical review of cases as required (including QC/QA role).

Authoring/Writing of Aggregate reports- PBRERs, PSURs/DSURs as well as Signal detection, analysis and management activities.

Work closely with SMEs to ensure medical resources have necessary training and skills per industry norms.

Support supervisor in hiring, training, managing and retaining medical resources.

Implement process & productivity improvements, as appropriate to improve operational efficiency.

Ensure compliance of operations with governing regulatory requirements

Create, maintain and assume accountability for a culture of high customer service.

Provide input/ feedback to the case processing team pertaining to medical judgment and medical queries.

Coalesce with updates from medical reviewers.

Responsible for identifying training needs and imparting training when needed.

Update and document daily case data, case-feedback in appropriate trackers/tools

Workflow management of cases assigned to medical review and ensure completion of all cases within regulatory timelines.

Undertake Primary/Secondary medical review of cases as required (including QC/QA role).

Role & Responsibilities

October 2012-May 2016

Safety Physician, Pharmacovigilance, Sciformix, Pune

Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.

Ensure compliance of operations with governing regulatory requirements

Create, maintain and assume accountability for a culture of high customer service.

Medical assessment of the case for seriousness, adverse event coding, labeling, narrative and causality.

Provide input/ feedback to the case processing team pertaining to medical judgment and medical queries.

Keep current with the regulatory requirements pertaining to prescribed products, medical devices and combination products.

Implement feedback from medical reviewers, consultants and subject matter experts.

Raise appropriate follow-up questions.

Coalesce with updates from medical reviewers.

Responsible for identifying training needs and imparting training when needed.

Update and document daily case data, case-feedback in appropriate trackers/tools

Workflow management of cases assigned to medical review and completion of all cases within stipulated timelines.

Provide medical review of complex advertising and promotional materials and non-promotional material and ensuring accordance with established policies and practice standards, including regulatory guidelines.

Provide training and guidance to process associates on medical aspects of case processing.

Perform retrospective review of cases reviewed (quality data) for measuring quality of deliverables, identifying error trends, training needs and areas of improvement.

Undertake Primary/Secondary medical review of cases as required (including QC/QA role).

September 2011-November 2011

Medical Reviewer, Safety Physician, Accenture Service Pvt Ltd

Review adverse event case reports to verify accuracy, consistency and completeness of the information.

Perform Company Causality assessment and provide Company Case Comment, where applicable.

Review, Rank and Confirm: Case Validity; Seriousness; Event term Selection; Expectedness/ Listedness/ Labeling; Adverse event Coding; Suspect products and Concomitant medications; Lab investigations; Special scenarios; Product complaints; Case Reportability and overall consistency of information.

Review and edit the Case Narrative; Generate queries and action items in case of inconsistent, missing or incomplete information.

Develop and maintain expertise and knowledge of: All assigned products within a therapeutic area; Applicable corporate and global Regulations and guidelines; Standard Operating Procedures; Writing practices and Style guides; Data entry conventions; and Search functions in the Safety Database.

January 2008-December 2009

Clinical Lab Quality Manager & Clinical Microbiologist NMC Super Specialty Hospital VIMHANS Hospital, Delhi

Provide diagnostic information for therapeutic support in the clinical management of patients.

Reporting on microbiological cultures and sensitivity testing, staining and serological testing.

Looking after Quality Control and Quality Assurance activities of the entire Laboratory services.

Looking after the ongoing NABL accreditation process.

Preparation of the laboratory, staff training and other related activities.

Actively participating in the bi-annual ISO audit pertaining to document updating, staff training,

Corrective and preventive actions, closing minor non- conformities, internal audits and other related activities.

Quality control and assurance of the laboratory tests.

Formation of Hospital Infection Control Committee, Hospital Restricted Anti -microbial policy and Hospital Waste Management policy.

Air surveillance of Operation Theaters, Intensive care units, Hospital Nursery and other High Dependency and Critical Care Units.

Participation in NABH accreditation process related meetings and updates.

Resolving manpower, bio-medical equipment’s maintenance and quality control and client queries pertaining to clinical implications of the test reports/results.

August 2004- August 2007

DNB Training Indraprastha Apollo Hospitals, Sarita Vihar, New Delhi

Strong technical knowledge in medical microbial methodology and processes.

Hands-on experience in microbial culture, preparation and routine microbiological laboratory techniques and methods.

Isolated, identified and characterized microbes using conventional and automated methods.

Actively participated in laboratory Quality Control and Quality Assurance activities.

Well versed with various conventional methodologies of identification of microbes. Hands-on Experience with various Automated Systems of identification of microbes like Bactec 9120 blood Culture system, Mini API system, Vitek – 1 and 2 systems, MGIT 960.

Knowledge of Hospital Infection Control Committee- Composition and Activities.

Training junior medical staff and technical staff.

Knowledge of serological procedures like, agglutination reactions (Tube, Slide and Latex), Nephlometry and maintenance of Quality control of various serological methods.

Knowledge of Advanced serological procedures like ELISA, IMMUNOCHROMATOGRAPHY, IMMUNOBLOT ASSAYS and maintenance of Quality Control associated with it.

Knowledge and Hands-on experience of molecular methods like- PCR and Real-time PCR.

Efficient in Microscopic examination of stained preparations (ZN, MZN, Gram’s, KOH, Indian Ink, Silver Methanamine, PAS) from various clinical samples like CSF, Body Fluids (Pericardial, Ascitic, Pleural, Synovial Fluids), Pus, BAL, Sputum etc.

May 2004-July 2004

Noida Medical Center Super Specialty Hospital Noida

Responsible for all the patients admitted to the in-patient department on one floor (10-16 patients) and providing back-up for other areas.

Assisted the specialist consultants on ward rounds.

Attended to all gynecological patients under supervision of a gynecologist.

Looked after the hospital’s nursery and Kidney Transplant Unit.

Provided a back-up for Emergency services under the supervision of the Chief Medical Officer.

January 2003-February 2004

Private Clinical Practice, Agra

Attending to and prescribing medicines to patients in private OPD (general practice and family medicine)

Recommending referrals and additional investigations to patients, as required.

January 2002-December 2002

Rotating internship, Sarojini Naidu Medical College, Agra

One year of compulsory rotating clinical internship at Sarojini Naidu Medical College. This included:

Attending patients in out-patient departments and in-patient departments

Managing patients in Emergency Services (Casualty) and night calls Across various disciplines including General Medicine, E.N.T, Ophthalmology, Orthopedics, General Surgery, Pediatrics, Radiodiagnosis, Obstetrics and Gynaecology and Social and Preventive Medicine

Publications

Thesis on “Bacteremia, Fungemia and Septicemia in Children below 16 years of age attending a tertiary care hospital - A study.” [Procalcitonin - A novel biomarker of septicemia was extensively studied in children below 16 years of age presenting to the hospital with sepsis, this study was first of its kind from India with some very interesting findings

Poster presentation entitled: “Nocardia Spp: In-sight, In mind.” at National Medical Microbiology Conference held at Nagpur, India

Workshops & Seminars Attended

Mycobacteriology procedures – How to do things right? [Bacten and Dickinson]

Viral Diagnostics, Epidemiology and Pathogenesis [Indo-US Symposium, AIIMS New Delhi]

Microcon 2006, [Government Medical College Hospital, Nagpur]

National Conference Hospital Infection Society- India [Apollo Hospitals, Hyderabad]

Indian association of Medical Microbiologists Delhi Chapter CME [Vallabhbhai Patel Chest

Institute, New Delhi]

Pediatric Intensive Care Update and Workshop [Indraprastha Apollo Hospitals, New Delhi]

Contact this candidate