Senior Medical Safety Advisor

Role : Senior Medical Safety Advisor

Total Experience : 5+ Years.

Pharmacovigilance / PV Experience : 1+ Years

Work location & Mode : PAN India -Homebased

Education : MBBS / MD Graduates.

Must Have Skills : Pharmacovigilance, ICSR.

Job Overview

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.

Essential Functions

Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary

Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements

Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data

Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported

Perform medical safety review of the protocol, Investigative Brochure, and / or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable

Provide aggregate reviews of safety information, including but not limited to clinical data, post marketing, literature review and observational studies to maintain oversight of a product’s safety profile (e.g : DSUR, RMP, PBRER, ad hoc regulatory reports etc)

Ensure service delivery from productivity, compliance and quality perspective within regulatory / contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective.

Provide therapeutic area / pharmacovigilance issue guidance in the context of leading / managing other safety team members in single case assessment.

Ensure update of watch list, list of expectedness, labeling list / RSIs etc for the assigned products and develop such additional capabilities within the team

Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives

Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable

Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable

Act as Lead Safety Physician, or additional team support, and / or back up on assigned projects as applicable

Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable

24-hour medical support as required on assigned projects

Maintain awareness of medical safety-regulatory industry developments

Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable

Qualifications

MBBS OR MD from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is required.

1+ years of pharmacovigilance experience and 5+ years of total experience is mandatory.

Sound knowledge of Medicine

In-depth knowledge of applicable global, regional and local clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Knowledge of Pharmacovigilance- ICSR.

In-depth knowledge of departmental standard operating procedures (SOPs)

Skill in use of multiple safety databases

Adequate Computer skills, especially Microsoft word, excel & PowerPoint

Good communication skills- verbal and written

Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives

Ability to establish and maintain effective working relationships with coworkers, managers and clients

A valid medical license, or equivalent, from the country or region in which he / she resides and works preferred.