Senior Medical Safety Advisor (a 12-month fixed-term contract)

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 products 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.

Main Responsibilities

Perform medical review and clarification of trial-related Adverse Events and post-marketing adverse drug reactions including narrative content queries coding expectedness seriousness causality and company summary.
Compose edit and medically review Analyses of Similar Events 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.
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 products 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.
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 expectednesess labeling list/RSIs etc for the assigned products.
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.
Act as Lead Safety Physician or additional team support and/or back up on assigned projects.
Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects.
24 hour medical support as required on assigned projects.

Required Skills and Qualifications

A Medical Degree and 3 years of experience practicing clinical medicine
At least 2 years of pharma experience
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 and Aggregate reports.
In-depth knowledge of departmental standard operating procedures (SOPs).
Skill in use of multiple safety databases
Ability to establish and maintain effective working relationships.
A valid medical license