Executive Director, Postmarketing Pharmacovigilance and Compliance

Conshohocken, PA
Pharmacovigilance /
Full Time /

Position Summary:

Reporting to the SVP, Head of Clinical Safety & Postmarketing Pharmacovigilance, the Executive Director, Postmarketing Pharmacovigilance & Compliance will play a key role in management of the Pharmacovigilance System Master File (PSMF), including Compliance and Inspection-readiness activities.  In addition, this role will serve as a mentor and resource for colleagues within the department and will assist as needed in key safety surveillance activities.
Provide comprehensive oversight of activities related to PSMF, including tracking of relevant pharmacovigilance processes and activities for compliance purposes, including but not limited to: quality surveillance, review of metrics, institution of any necessary additional monitoring (e.g., Corrective Action and Preventative Actions [CAPAs] and Quality Event deviations, assistance with product incident reviews and coordination of inspection readiness activities.
Proactively develop and implement within PV department plans regarding quality, compliance and inspection readiness across Drug Safety & Pharmacovigilance department (both Clinical Safety & Postmarketing Pharmacovigilance)
Attend cross-functional Safety Review Team meetings for in-depth product understanding of safety profile of Madrigal products to aid in quality review of pharmacovigilance system and documents
Review and provide PV input for development and tracking of Postmarketing protocols, other relevant Postmarketing Commitments and key safety documents of interest
Perform QC review of aggregate safety reports, e.g., Periodic Benefit Risk Evaluation Reports (PBRERs), Risk Management Plans (RMPs) and other safety sections of key documents (including both internal only & regulatory submissions)
Support vendor management regarding Qualified Person for Pharmacovigilance (QPPV) activities, including QPPV Project Plan
Lead development and maintenance of Safety Data Exchange Agreements
Provide subject matter expertise and input for regulatory submissions, e.g., NDA, MAA and regulatory responses, collaborating with cross-functional areas as appropriate
Degree in Pharmacy, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV or Clinical Drug Safety Monitoring
Minimum 20 years of pharmaceutical industry experience, including a minimum of 15 years of working directly in pharmacovigilance, ideally with experience in both Postmarketing Pharmacovigilance and Clinical Safety
Knowledge of global safety regulations, MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases.  Prior experience entering data and/or reviewing data within system a plus
Thorough understanding of the drug development process and context applicable to safety surveillance activities
Experience reviewing cumulative safety data with ability to interpret, synthesize, communicate, and present complex clinical /pharmaceutical information
Experience in the preparation and authoring of pre- and post- aggregate safety reports, RMPs and process documents
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
Excellent communication skills and ability to influence across multiple functions