The Director/Senior Director, Product Safety and Pharmacovigilance is a highly scientific and mid-level leadership role that requires medical and safety expertise as the Product Safety and Pharmacovigilance representative on the product clinical development team. In addition, he/she manages and conducts ongoing safety surveillance for assigned products. Also, oversees the preparation of NDA safety updates, IND safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary. Additionally, he/she collaborates with cross-functional groups and other regional safety counterparts to update them on medical assessment, safety signal detection, and risk management practices in the US and international markets.
The candidate will have broad knowledge and perspective of drug safety in pharmaceutical/biotech industry and clear understanding of safety reporting requirements and experience in global regulatory environment and processes.
MAJOR RESPONSIBILITIES
- Provide medical and safety expertise as the Medical Safety and Pharmacovigilance representative on the product clinical development team.
- Lead the preparation and delivery of high quality, consistent and compliant safety information for regulatory submission documents (including IND and NDA).
- Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents including Investigators Brochures, clinical trial protocols, informed consent forms, safety management plans, clinical study reports, integrated safety summary and summary of clinical safety.
- Manages and conducts ongoing safety surveillance on assigned products. Oversees the preparation of NDA safety updates, IND safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary.
- Co-organize, prepare and conduct safety management team meetings for assigned products and responsible for safety surveillance, signal detection and risk management.
- Coordinates the new development or maintenance of internal SOPs/WIs to ensure the uniform and timely processing of adverse event reports. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements.
- Applies general safety signal management methodologies and product specific signaling strategies to monitor for emerging issues related to assigned products.
- Ensure that the safety profiles of assigned HMP products are accurately and consistently represented in relevant labeling documents, identify and lead updates as required.
- Perform medical review of individual case safety reports (ICSRs) for assigned products.
- Collaborate with cross-functional groups and other regional counterparts to update them on medical assessment, signal detection and safety risk management practices in the US and international markets
- Identify opportunities and manage continuous improvement initiatives as related to medical assessment of pharmacovigilance data.
- Assist in the creation, review and implementation of SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk minimization.
QUALIFICATIONS
- Physician (MD, DO, or equivalent) or PharmD, or PhD in Nursing/Pharmacy with minimum 6-10 years related experience in clinical safety and pharmacovigilance.
- Experience in the oncology therapeutic area is preferred.
- Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and global safety regulations are highly preferred.
- Experienced in global regulatory environment and processes (US, UK, EU, AU, JP), and the ability to integrate safety medical knowledge with regulatory and commercial input.
- Ability to critically evaluate safety data from multiple sources (clinical trials, animal studies, post-market environment, literature, etc), assess clinical importance, benefit risk and potential strategic impact of the data and present the findings clearly in both written and oral communications.
- Experienced in writing/review of aggregate safety documents (DSUR, PSUR, and PBRER etc.) and risk management plans.
- Thorough understanding of US and European pharmacovigilance regulations, GCP and ICH guidelines.
- Demonstrated knowledge of biostatistics and epidemiology are preferred.
- Good ability to interpret complex clinical data and experimental results.
- Working knowledge of validated drug safety database (preferably ARGUS) and MedDRA.
- Ability to influence, negotiate and communicate with both internal and external stakeholders.
- Excellent English (writing and speaking) and excellent mastery of English medical terminology.
