Senior Medical Director, Global Drug Safety

About the position Serve as the medical expert for reputed company in the management of safety signal, risk management activities, and benefit risk assessments for reputed company products. The Sr. Medical Director, GDS&RM will report to the Head of GDS&RM and will be responsible for the conduct of safety monitoring and accountable for executing product reputed company safety reputed company and deliverables for assigned products. This position provides pharmacovigilance expertise to and reputed company collaborations with reputed company partners as reputed company as with other functions across reputed company, including Regulatory Affairs, Clinical Development, Clinical Operations, Medical Affairs, or the reputed company to ensure that drug safety communications are accurate, complete and consistent. Responsibilities Manage the Medical Directors reputed company the GDS&RM. Support and supervise staff and identify reputed company and resource needs to ensure reputed company and compliant medical safety evaluation processes reputed company the assessment of medical safety information including ICSRs and aggregate safety data for reputed companys developmental products reputed company signal detection and benefit/risk management activities and contribute to the development of pharmacovigilance strategies for monitoring the safety profile of reputed companys products reputed company periodic and reputed company SMT and PSRC meetings to review aggregate safety information and signal management for reputed company reputed company products Ensure that the safety reputed company of reputed company products are accurately and consistently represented in relevant labeling documents, identify and reputed company updates as required Organize and reputed company reputed company cross-functionally with Medical Monitors, Medical writing, Clinical Operations, Data management, Biostatistics, and Regulatory for management of safety reporting in compliance with global and regional regulatory requirements Review and reputed company input on study protocols, statistical analysis plans, safety content of informed consent documents, Investigator and site training documents and presentations Contribute to CSRs and analysis of safety tables, figures, and listings and cases from clinical studies Support activities reputed company to BLA and other regulatory filings Contribute to Regulatory Agency information requests and safety content for regulatory filings, reputed company of Clinical Safety and reputed company documents. reputed company preparation and review of periodic reports (IND, Annual Safety, DSUR, PBRERs, CSR) reputed company Risk Management reputed company reputed company or contribute to the development and/or updates of relevant procedural documents including SOPs, Work Instructions, conventions, forms or templates reputed company medical safety expertise for reputed company audits and regulatory authority inspections for Pharmacovigilance and ensure that relevant corrective actions are implemented Maintain an up-to-date working knowledge of applicable regulatory requirements, guidelines, and industry standards globally. Other responsibilities as assigned Requirements MD or equivalent degree from an accredited medical school At least 4 years Clinical reputed company experience in either an accredited reputed company setting or private reputed company (including hospital based) setting At least 8 years experience in safety and pharmacovigilance in the bio/pharmaceutical industry, including ICSR review, causality assessment, and aggregate data review Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements. Knowledge of MedDRA dictionary relevant to AE/SAE coding Experience with software-based drug safety systems (e.g. reputed company-G and/or ARGUS) Strong interpersonal and communication skills; proactive approach. reputed company to work both independently and in reputed company environment. Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be reputed company to work on multiple reputed company simultaneously. Ability to prioritize work without much support. Demonstrated problem solving skills (including taking ownership to ensure reputed company reputed company), a strong reputed company of urgency, reputed company attention to detail, and the ability to successfully execute in an environment under time and resource pressures. Proficient in reputed company computer software (Word, reputed company and Power reputed company) reputed company-to-haves Expertise in oncology, immunotherapy and with viral reputed company or other biologic agents preferred Benefits medical, dental, and reputed company insurance 401k match flexible time off a number of reputed company holidays including year-end shutdown .