Director, Global Safety Lead

Primary Responsibilities

• Spearhead signal detection activities, including kickoff, planning, safety data retrieval and analysis, and authoring of sections of the Safety Evaluation Report (SER) or Development Safety Evaluation Report (DSER) for development and marketed compounds
• Generate and coordinate aggregate safety reports (PBRER, PSUR, PADER, DSUR, INDAR, 6-monthly line-listings, etc.) for development and marketed compounds, including kickoff activities, planning, safety data analysis, authoring of select sections, and validation of appendices
• Lead coordination of risk evaluation and mitigation activities for development and marketed compounds, including safety data analysis and authoring of sections of the Development Risk Management Plan (DRMP), RMP, REMS, etc.
• Prepare and review safety sections of key documents (concept sheets, protocols, ICFs, CSRs, etc.), validate CRF AE/SAE pages, and participate in User Acceptance Testing
• Conduct safety reviews and perform periodic quality checks of vendor-generated ICSR databases
• Document the Analysis of Similar Events (AOSE), including safety data analysis and drafting of the analysis report
• Contribute to and support regulatory filings (NDA, sNDA, MAA) and respond to Health Authority queries or interactions, covering clinical and post-marketing commitments
• Represent the Medical Safety Division on project, medical safety, and study teams as required
• Maintain and update safety sections of the CCDS/CCSI and corresponding datasheets (CCDS/CCSI/RSI/IB or local PI)
• Develop and update SOPs, forms, operating manuals, and document templates related to safety activities
• Guide and support newly hired Global Safety staff, trainees, apprentices, or external service providers
• Act as Global Safety representative during audits and inspections, as needed
• Champion initiatives outside of assigned projects/compounds, as needed

Education and Required Skills

• Medical Doctor (MD) or PharmD required, with a minimum of 10 years of experience; experience in drug safety across pre-approval (early to late-stage) and post-approval settings preferred
• Demonstrated knowledge of pharmacovigilance and risk management, including:
  • Experience producing aggregate safety reports and conducting signaling activities
  • Knowledge of applicable safety regulations, including those governing clinical trials
• Strong Microsoft Excel, Word, and PowerPoint skills
• Advanced written and verbal communication skills
• Demonstrated ability to balance multiple competing priorities and drive tasks forward in a fast-paced, global environment
• Proven success in cross-functional collaboration
• Strong capability to analyze data from a wide range of sources