Director, Drug Safety & Pharmacovigilance
- Lead ongoing safety review and signal detection, evaluation, and management activities for development assets
- Supports build out of safety analytics and reporting infrastructure, such as developing standard procedures and templates
- Author, review, and approve aggregate safety reports, including DSURs, PBRERs/PSURs, and ad hoc safety assessments.
- Serve as the lead/coordinator and key contributor for internal Safety Review Committees or other safety governance bodies at the trial and asset level.
- Provide expert safety science input for key regulatory and clinical documents, such as protocols, informed consents, Investigator's Brochures, Clinical Study Reports, and integrated summaries of safety
- Strategizing and drafting of responses to regulatory inquiries on safety issues inclusive of defining MedDRA search strategy
- Supports activities related to new drug applications and other regulatory filings
- Represent drug safety at regulatory inspections i.e. MHRA, FDA, EMA, etc
- Serve as the primary point of contact and relationship manager for outsourced PV CRO vendor(s), ensuring a collaborative and effective partnership.
- Oversee CRO vendor budget, review invoices, and participate in contract renewals and negotiations.
- Establish, monitor, and report on Key Performance Indicators (KPIs) and quality metrics to ensure the CRO's adherence to timelines, regulatory requirements, and quality standards.
- Provide oversight of the CRO's case processing (ICSR) and regulatory reporting activities, ensuring all safety data is handled with the highest level of accuracy and compliance.
- Supports safety database and clinical database adjudication
- May lead gap analysis to ensure alignment with changes in global regulations
- Advanced degree in a biologic/medical/clinical/nursing field required (PharmD, Nurse Practitioner, Ph.D.)
- At least 8 + years’ experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry. Experience working in a start-up environment is desirable.
- Deep knowledge and understanding of US and EU safety regulations pre-and post-marketing
- Demonstrated expertise in signal detection, risk management, and authoring aggregate safety reports for both investigational and marketed products
- Strong experience with clinical development including risk/benefit analysis and safety assessment
- Experience directly managing CROs, PV service providers, or other outsourced vendors
- Experience successfully leading or playing a key role in regulatory authority interactions and inspections.
- Strong analytical, problem-solving and scientific writing and communication skills
- Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
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