Executive Medical Director of Drug Safety and Pharmacovigilance
Executive Medical Director of Drug Safety & Pharmacovigilance
The Executive Medical Director of Drug Safety and Pharmacovigilance will be responsible for providing medical leadership for clinical safety, pharmacovigilance and risk management activities.
The successful candidate will function within the company matrix team environment, interacting with several key stakeholder groups including but not limited to; Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Research and Legal.
- Be the primary representative of the Drug Safety team in clinical development projects providing expert medical guidance on safety matters for investigational products. Responsible for the evaluation and communication or production of appropriate documents for safety alerts/signals, development risk management plans, reference safety information and safety evaluations of emergent safety issues.
- Provide medical safety oversight in clinical trials. Participates in protocol development, specifically the collection and monitoring of safety data in interventional and observational studies, statistical analysis planning, medical review of trial related data including, adverse events/SAEs, evaluation of safety data and reporting of study data.
- Provide leadership on clinical safety content of country marketing applications e.g. NDA/MAA Clinical Safety Summary and REMS/Risk Management Plan.
- Contribute to preparation and review of periodic safety reports (DSUR, EAP Reports, etc.)
- Provides leadership for IB section "Guidance for Investigators" and other safety sections.
- Lead the product risk management strategy and facilitates production and maintenance of risk management plans.
- Perform medical review oversight for individual case safety reports (ICSRs) from post-marketing sources.
- Provide medical input to design and maintenance of REMS programs, monitoring of REMS goals and provision of REMS Assessment Reports.
- Lead benefit-risk discussions at the safety governance committee, provide recommendations, facilitate agreements and collaborate or lead for the implementation of risk minimization actions.
- Conduct medical evaluation of relevant safety-related information from toxicology, non-clinical studies, as well as product quality complaints, as needed.
- Contribute to preparation and review of periodic safety reports (FDA PADERs, Enhanced PV Plan Report, PBRER, etc.).
- Contribute and provides leadership in formulating responses to Regulatory agencies related to post-marketing pharmacovigilance.
- Participate in leadership oversight of safety vendors
- Participate in the strategic thinking and continuous improvement activities of self as well as Drug Safety department including systems design and quality management activities.
- Contribute to development of the Drug Safety department through involvement in recruiting/coaching talent and fiscal management.
Key Skills, Abilities and Competencies:
- Competent in safety reviews of clinical safety data/documents including AEs/SAEs, IBs, protocols, clinical study reports and informed consent documents and safety submissions (CTD clinical safety summary).
- Knowledge of GVP, GCP, ICH guidance and safety regulations.
- Ability to communicate and collaborate effectively in a matrix environment.
- Excellent written and oral communication skills.
- Good judgement and decision-making skills, including identification and communication of relevant safety-related issues or concerns to Drug Safety Management in an appropriate and timely manner.
Qualifications and Experience:
- M.D. with solid knowledge and clinical practice experience of General Medicine.
- Clinical Development and Post-marketing pharmacovigilance experience required.
- 10+ years pharmacovigilance experience.
Sthree US is acting as an Employment Business in relation to this vacancy.