SAHANA RAMANATHAN

*** ******** ***** *** 973-***-****

Apex, NC-27523 adjpc1@r.postjobfree.com

Summary:

8+ years of Pharmaceutical experience as a Drug Safety Specialist.

Experience in processing and vendor management of both clinical trial and post-marketing drugs.

Sound knowledge of ICH –GCP guidelines, US FDA and EMEA regulations.

Process Lifecycle Safety data according to applicable regulations, guidelines, SOPs and project requirements.

Demonstrated competence in triaging, evaluating, processing of clinical and spontaneous cases including pregnancy cases and reviewing AE and SAE reports from various sources in compliance with the regulations without compromising the quality of work.

Assess incoming reports for completeness, legibility, validity, seriousness, causality and expectedness.

Review, evaluate and verify potential AE information to determine required action per internal policies and procedures.

Strong understanding of Pharmacovigilance, solicited, literature, and device related cases, single case processing & spontaneous cases in ARGUS and ARISg.

In-depth understanding of coding through MedDRA and WHO Drug Dictionary. Review and perform disease and medication coding. Responsible for coding all medical history, events, drugs/ procedures, laboratory tests and indications.

Utilize labeling lists for determining expectedness & seriousness of AE and SAE.

Generate well-written case narratives

Support role involved in regulatory reporting to MHRA, US- FDA, AIFA, BFARAM, EU region and commend over case reviewing, ICH-GCP, Volume 9A, GMP& GLP guidelines along with IT skills of MS Excel preparations.

Assist in reporting and submission of expedited safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with the regulatory timelines and the project-specific contractual agreement. Ensure monitoring of the successful transmission and E2B case failures.

Perform vendor oversight activities by interacting and monitoring with vendor's (CRO’s/ Licensing partners) case processing work, quality and compliance metrics on regular basis to ensure timely processing of adverse events reports for all investigational and marketed products.

Assist in the work flow lead activities such as study set up, running due date report, write deviations (planned and unplanned) and document quality issues in conjunction with the Quality and compliance group. Analyze the root cause and propose corrective and preventive action plan (CAPA).

Perform safety database super user activities such as performing user acceptance testing (UAT).

Create and maintain workflow trackers, flow charts, Power Point slide presentations as needed.

Assist with running line listings for the aggregate reports such as PSURs, PADER, DSURs, IND, NDA and RMP Updates using Oracle tool on company safety database.

Experience working with medical directors, safety physicians and other department management personnel during project team meetings.

Facilitating and implementing the initiatives at an organization level and executing continuous process improvement projects at process level.

Provide new hire (onboarding) Argus training within DSPH and CROs as required.

Participated in SOP review, and project related audits and inspections including internal audits, and client audits.

Skills

Details

Safety Database

ARGUS & ARISg

Clinical Database

Medidata RAVE & Inform

Technical Skills

MedDRA, SOPs, SAE-SAR Reporting, Concise Narratives, WHO Coding, Aggregate reporting, Regulatory reporting.

Computer Skills

MS Office (Word, Excel, Access, PowerPoint)

Therapeutic Experience

Indication

Years

Cardiovascular

Acute Coronary Syndrome, pulmonary arterial hypertension (PAH), radionuclide myocardial perfusion imaging (MPI), chronic angina

3

Central Nervous System

Alzheimer's Disease

3

Autoimmune Disease

Rheumatoid Arthritis

3

Hematology/Oncology/Transplantation

Small Cell carcinoma of Lung, Chronic anemia, Bone marrow Failure, Myelofibrosis & Polycythemia Vera, thrombocytopenia, relapsed or refractory large B-cell lymphoma, chronic lymphocytic leukemia (CLL), B-cell non-Hodgkin lymphoma (FL), lymphocytic lymphoma (SLL)

5

Diabetes

Type 2 diabetes mellitus

1

HIV/ AIDS

chronic hepatitis B virus (HBV) infection, HIV

0.5

Liver disease

Chronic hepatitis C virus (HCV) infection

0.5

Ophthalmology

Neovascular (wet) Age related macular degeneration (AMD), Macular edema (ME), retinal vein occlusion (RVA), Diabetic retinopathy (DR) and Diabetic macular edema (DME)

0.5

Respiratory

Cystic fibrosis (CF), Influenza infection

0.5

PROFESSIONAL EXPERIENCE:

Safety Specialist II (Full Time) Precision for Medicine, Remote based Aug 2018-Present

Interfaces with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.

Provides safety services for Agility clients, including intake, triage, preparation and/or review of safety reports, including case narratives and analyses of similar event statements.

Manages Individual case safety reports (ICSRs) and aggregate data from clinical trials and post-marketing reporting, and develops project specific safety plans, tools, and templates for the collection and management of safety data in accordance with global regulations, ICH guidelines and project specifications.

Evaluates applicable safety data for completeness and accuracy and discerns which information requires querying.

Interacts closely with reporters, internal and external team members, and vendors until all follow-up information is obtained and queries are satisfactorily resolved.

Coordinates with internal or external data management team member regarding reconciliation of safety data between the clinical and safety databases.

Review of clinical data or data from the published literature.

QC of documents and safety reports.

Reviews and/or drafts standard operating procedures, work instructions, and/or manuals.

Codes adverse events, medical history, concomitant medications, tests, and medications/treatments.

Participates in the assessment and set-up of a safety database to capture safety data.

Assists clients and / or other Agility staff with safety-related reviews and other services.

Prepares and/or reviews safety training materials.

Provides safety training and oversight for consultants, contractors and/or staff.

Proactively communicates to management new issues and suggested solutions.

Perform lead activities and facilitate meeting with sponsor.

Coordinates workload /workflow and provides updates to internal and external mean members.

Maintains knowledge of ongoing projects and disease-related terminology.

Presents training materials to potential clients, sponsors, vendors, and internal and external team members on safety-related processes, procedures, or capabilities.

Follows applicable regulations, including FDA, ICH, HIPAA, GCP, GDP, and Agility Clinical Policies and Procedures.

Performs other work-related duties, as assigned.

Drug Safety Specialist, Quality Management (Contractor) Gilead Sciences, Foster city, CA Jul 2017-Jan 2018

Safety Specialist, Operations Support team within DSPH Operations

Establish work priorities and direction with input from Manager.

Provide new hire (onboarding) Argus training within DSPH and CROs as required.

Assist in development and maintenance of Ops Support training materials as required.

Provide training to DSPH Operations personnel on Gilead data entry conventions as required.

Assist with other Operations Support training activities as required.

Perform quality control (QC) checks for data entered for ICSR reports from both investigational and post marketing products to ensure accuracy and compliance with Gilead conventions and regulatory standards.

Ensure that the events, medical history, laboratory tests, procedures and drugs have been coded appropriately using the MedDRA and WHO drug dictionary accordingly.

Provide feedback on results of QC check to DSPH operations case owners and Managers.

Collate findings from QC checks.

Seek assistance from appropriate internal and external resources.

Interact with other DSPH functional areas to QC ICSRs efficiently and accurately.

Identify issues/concerns in a timely and appropriate manner and communicates these to manager.

Remain current with case handling SOPs, WRKs, manuals and database technology.

Organize individual workload to ensure compliance with PVA and other global regulatory reporting requirements.

Ensure departmental workflow processes and timelines are followed.

Understand DSPH Business Continuity processes, as applicable.

PV Operations Senior Specialist (Contractor) Regeneron Pharmaceuticals, Tarrytown, NY Nov 2016-April 2017

Interacts with case processing vendor on regular basis to ensure timely processing of adverse events reports for all investigational and marketed products.

Ensure appropriate coding of events and drugs using MedDRA and WHO drug dictionary.

Evaluates all adverse event reports received from the case processing vendor for accuracy and regulatory reporting. Monitors case finalization work stream and prepares reports for distribution.

Perform distribution of the SUSAR reports (CIOMS and XML) to various CRO’s for cross reporting. Perform E2B submissions to the licensing partners.

Performs vendor oversight activities by monitoring vendor's case processing quality and compliance metrics

Independently interacts with LPs as needed to support case processing deliverables in accordance with applicable regulations in accordance to license partner agreements.

Perform unblinding of the subjects for clinical trial studies as required.

Works closely with medical affairs personnel for PV deliverables related to post-marketing studies/programs

Works closely with Regulatory personnel for regulatory submissions of adverse event reports. Well versed with uploading the cover letter and Medwatch to content management system (VeevaVault) for FDA IND submissions.

Liaise with Medical Information and Commercial leads to manage vendors and personnel directly involved with PV deliverables.

Exercises independent judgment in managing case processing PV deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.

Leads and/or contributes to continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to internal PV Ops deliverables.

Ensures development and maintenance of applicable SOPs, Working Practices and trainings.

Frequently interacts with collaborators, and functional peer groups at various management levels within and outside the organization to support vendor management and case processing deliverables. Interaction typically requires the ability to gain cooperation of others, conducting presentations of PV related information concerning specific projects or schedules.

Drug Safety Associate (Contractor) Incyte Corp, Chaddsford, PA Aug 2015-Jul2016

Oversee the receipt, assessment, tracking, follow-up and reporting of SAEs.

Assist CROs with the receipt, assessment, tracking, follow-up, and regulatory reporting of adverse drug experiences received by Pharmacovigilance. Triage events for expectedness and reportability along with the CRO.

Review adverse drug experience reports entered into the Safety Database by a CRO. Review the narratives, follow-up requests, and coding adverse events in MedDRA in conjunction with medical monitors and prepare line-listings and narratives as requested for safety reviews.

Assist with submission of expedited reports via the CRO to Health Authorities globally. Ensure compliance with internal procedures, regulatory requirements and contractual requirements of Safety Data Exchange Agreements (SDEA) with business partners. Manages expedited submission history in safety database and tracks reporting compliance with regulations.

Ensure compliance with internal procedures, regulatory requirements and contractual requirements of. Manages expedited submission history in safety database and tracks reporting compliance with regulations.

Responsible to perform E2B submissions per standardized operating procedural document, review ICSRs for local reportability to the regulatory authority and to the licensing partner, make submit / no submit determination and monitor successful transmission.

Monitoring the transmissions / E2B case failure monitoring and reach out to the respective technical team for escalation.

Contribute to the timely preparation of ad-hoc and aggregate reports, including DSURs monthly SUSAR Line-Listing Reports, IND annual reports, liaising with managers, physicians, and Pharmacovigilance colleagues as appropriate.

Prepare and maintain internal filing systems; archives safety files and scans source information for archival in electronic systems. Collaborate with internal departments to supports and develop standard operating procedures/working practices/collection forms and adheres to company and departmental SOPs as required.

Assists with creating policies, SOPs, work instructions, forms and templates for efficient and effective processing of ICSRs and aggregate reports.

Identify areas for process improvement (specifically regarding quality) and possible areas for retraining for individuals/team.

Use medical/pharmacological expertise to assist with data review, literature review and signal detection processes.

Demonstrate ability to communicate effectively with personnel of various disciplines both inside and outside of the company, regarding aspects of product inquiries and collection of safety data.

Associate Operations Specialist (Contractor) Quintiles / IMS, RTP, NC Dec 2011-Jul 2015

Receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards.

Assess incoming reports for completeness, legibility, validity, seriousness, causality and expectedness.

Ensure that reports are compliant with ICH guidelines, FDA requirements, and internal SOP’s.

Perform data entry of the unstructured case data from the source documents and assess adverse event reports from clinical trials, post-marketing, both serious and non-serious in safety database within global and local timelines.

Perform consistent coding of diseases and adverse events using MedDRA according to the project-specific coding conventions in the Safety Database assessing reportability of ICSRs.

Verify and check drug coding, as prescribed by regulatory guidelines, to ensure that trade names are correctly translated into INN in the database. Ensure appropriate coding of company drugs using CPD and other drugs using WHO-DD.

Review appropriate labeling documents such as IB, CCDS, SPC and USPI for assessing the expectedness and consulting the Medical Safety Expert whenever needed.

Review source documents, medical records and literature documents. Generate clear, concise and comprehensive narratives procured from relevant, related information from various source documents.

Generate queries pertinent to the case, performing quality control, assisting with SAE reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines.

Perform follow ups via fax, email, telephone and query questionnaires for clarification and completeness of a case.

Upon receipt of the triggers received via the project mail box, utilize the company tracking database, clinical database, and safety database and perform the pass-through submission of the source documents to the sponsor.

Assess Lifecycle Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, and investigators, oversight groups per legislation, within timelines and in a format compatible to requirement.

Worked in conjunction with Clinical Safety Associates, Clinical Safety Scientists from other processing sites and Medical Safety Physicians (Pharmacovigilance Leader and Brand Safety Leader) to ensure that reports are accurately evaluated and all the required updates are incorporated.

Liaise with local Quintiles offices to facilitate expedited reporting. Regulatory reporting to MHRA, US- FDA, AIFA, BFARAM and EU region. Liaise with systems manager for regulatory tracking requirements and electronic reporting.

Support role involved in creation of listings using Oracle BI tool on company safety database.

Assist in the work flow lead activities such as running due date report, write deviations (planned and unplanned) and document quality issues in conjunction with the Quality and compliance group. Analyze the root cause and propose corrective and preventive action plan (CAPA). Prepare job aids and provide mentorship to the new employees as needed.

Served as study safety lead for client projects. Communicate with client for study start up and close out activities.

Perform safety database super user activities such as performing user acceptance testing (UAT), and case management activities.

Participated in SOP review, and project related audits and inspections including internal audits, and client audits

Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.

Achievements: Awarded with ‘Star of the team’ for maintaining 100 % Compliance and good quality case reports.

PAST EXPERIENCE:

Research Associate Becton and Dickenson, NJ 01/2010

INTERN EXPERIENCE:

Forensic Toxicology NYC office of Chief Medical Examiner, NY 05/2009

EDUCATION:

Masters, Forensic Science University of Central Oklahoma, Edmond, Oklahoma 07/2009

Bachelors, Biotechnology Bangalore University, Bangalore, India 07/2004

AWARDS AND ACCOMPLISHMENTS:

Certification: Fundamentals of GCP, 2014

Awarded star of the week for maintaining 100 percent quality and compliance at Quintiles, RTP, NC (2013)

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