Provide medical and safety expertise as the Product 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, safety management plans, study reports, summary of clinical safety and risk management plans.
Manage and conduct ongoing safety surveillance on assigned products. Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary.
Organize and conduct safety management team meetings for assigned products and be responsible for safety surveillance, signal detection and risk management.
Coordinate the development of guidelines and ensures the uniform and timely processing of adverse event reports. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory safety reporting requirements.
Ensure that the safety profiles of assigned HMP products are accurately and consistently represented in relevant labeling documents and aggregate safety reports, identify and lead updates as required.
Provide support for medical review of individual case safety reports (ICSRs) for assigned products.
Collaborate with Chinese counterparts and other functional team members 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 related to safety assessment of pharmacovigilance data from all sources.
Assist in the creation, review and implementation of SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management.
Physician (MD or equivalent) with minimum 6 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 safety assessment of drugs and global safety regulations are highly preferred.
Experienced in global regulatory environment and processes, and the ability to integrate safety medical knowledge with regulatory and commercial input.
Ability to critically evaluate safety data from multiple sources (clinical trials, 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 PV documents (DSUR, PSUR, and PBRER etc.) and risk management plans.
Thorough understanding of US and EU 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.