Summary
The Associate Director of Safety and Pharmacovigilance will be an integral part of the Global Patient Safety and PV team, supporting both PV operations and safety science/risk management activities for assigned investigational and marketed products. The individual will contribute across case/vendor oversight, compliance, signal management, aggregate reporting, and benefit-risk evaluation.
Responsibilities
General
- Ensure adherence to report timelines and communicate issues to management as appropriate
- Develop and maintain an expert understanding of the latest safety regulations, technology, and safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease indication, safety profile of competitors, mechanism of action)
PV Operations/Quality Assurance
- Manage and support the relationship with safety vendors to ensure effectiveness, quality and compliance of all outsourced activities in collaboration with Director of PV operations.
- Lead oversight of quality and key performance indicators (case processing and aggregate reports) and present findings to Head of PV and relevant cross-functional stakeholders.
- Serve as resource for inspections and audits
- Ensure operational outputs support high-quality scientific safety assessment
Clinical Safety and Safety Science
- Lead signal detection and management activities, including literature search, data analyses, preparation of safety data for cross-functional safety team meetings, and drafting presentations and regulatory responses, in collaboration and consultation with the safety physician.
- Lead the drafting of safety sections of IB, aggregate reports (e.g. PADERs, PSURs, PBRERs, DSURs), and Risk Management Plans etc., in collaboration and consultation of the safety team and the cross-functional teams.
- Support and contribute to global regulatory submissions (e.g. drafting response to Health Authority requests, authoring and reviewing submission packages, etc.) with the safety team and the cross-functional experts.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
Qualifications
Education
- Bachelor’s Degree in a scientific, life sciences, or medical field; advanced degree in life science, epidemiology, or (certification/licensure) in Nursing or pharmacology preferred
Experience
- Minimum 8 years of experience working within Pharmacovigilance, experience with both PV operations and clinical safety/safety science (e.g., signal detection, risk management, regulatory responses) required
- Experience with neurology or autoimmune diseases preferred
- Advanced knowledge of safety databases (i.e., Argus), MedDRA coding, signal detection, aggregate reports, and RMPs required
- Understanding of how AI can be applied in Pharmacovigilance is a plus
Skills
- Advanced knowledge of Good Pharmacovigilance Practices – both U.S. and European Regulations and Directives, CIOMS/MedWatch
- Advanced knowledge of Working Group, Code of Federal Regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- Excellent ability to analyze and effectively communicate product safety information
- Demonstrates an attention to detail, results oriented, and good organizational skills
- Self-motivated with the ability to work both independently and collaboratively within a team environment
- Ability to adapt quickly to a changing business environment
