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 BRM pharmacovigilance process.
The Sr. Pharmacovigilance Physician (Sr. PVP) has additional responsibility to those of the Pharmacovigilance Physician in that the incumbent is expected to play a greater role as a senior technical leader and participate more fully 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. This will be demonstrated by preparing sections of aggregate safety reports such as PSURs, ad-hoc regulatory reports, Risk Management Plans etc. Interpretation of surveillance and product quality data.
In addition, the Senior Pharmacovigilance Physician will work in conjunction with the Safety Surveillance Group and be responsible for surveillance activities for selected products.
Medical evaluation of individual adverse event case safety reports, including but not limited to all serious and expedited reports and all pregnancy reports.
Accountable for review and interpretation, analysis and summarization of aggregate safety data from all sources including spontaneous, clinical, post-marketing and observational studies, literature review and product quality, (e.g. RMP, PSUR, ad-hoc regulatory reports, etc)
Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing a Pharmacovigilance Physician product team and/or technical leadership in single case assessment.
Participate in signal detection efforts, e.g. strategy meetings for PSURs and periodic reports and structured surveillance programs and execution of pharmacovigilance components of Risk Management Programs and related activities including assessment of potential signals
Lead or participate as members of pharmacovigilance matrix-teams responsible for pharmacovigilance activities focused on individual products and therapeutic areas.
Responsibilities include training activities, participation in selected reviews of aggregate reports such as PSURs, PADERS, contributing to the development and implementation of risk minimization action plans, etc.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
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 Harmonisation (ICH) guidelines
Knowledge of Pharmacovigilance- ICSR & Aggregate reports
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 & 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