Director, Global Safety Lead

Role Summary

The Director, Global Safety Lead will collaborate closely with Global Safety Leads based in Boston, MA (USA) or Suresnes (France) as part of the Global Safety organization. In this role, the individual will lead safety and risk management activities for assigned development and marketed compounds, in line with internal procedures and regulatory requirements.

Responsibilities include medical review, participation in drug safety related activities associated with clinical development, signal detection and evaluation, preparation of aggregate safety reports, and contributions to benefit-risk assessments and safety risk management strategies.

Primary Responsibilities

• Spearhead signal detection activities, including kick off activities, planning, safety data retrieval and analysis, authoring some sections of the Safety Evaluation Report (SER) or Development Safety Evaluation Report (DSER), etc. for development and marketed compounds
• Generate and coordinate aggregated safety reports (including PBRER, PSUR, PADER, DSUR, INDAR, 6 monthly line-listings, etc.), both for development and marketed compounds (including contribution in set up of kick off activities, planning, safety data analysis, authoring of some sections, validation of appendices
• Lead the coordination of risk evaluation and mitigation activities, both for development and marketed compounds, including analysis of the safety data and authoring of some sections (Development Risk Management Plan [DRMP], RMP, REMS, etc.)
• Prepare and review safety sections of documents (concept sheets, protocols, ICF, CSR, etc.) as well as CRF AE/SAE page validation and participation in User Acceptance Testing
• Conduct safety reviews and perform periodic quality checks of vendor-generated databased ICSRs
• Document the Analysis of the Similar Events (AOSE), including analysis of the safety data and drafting of the analysis report
• Contribute to and support regulatory filings (NDA, sNDA, MAA) and Health Authority queries or interactions (covering clinical and post-marketing commitments)
• Represent Medical Safety Division in project team/medical safety team and study teams as required.
• Maintain and update safety sections of the CCDS (CCSI) and datasheets corresponding to the 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 with audits and inspections, as needed
• Champion initiatives outside of the 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 pre-approval (ranging from early to late-stage) and post-approval settings preferred
• Demonstrated knowledge of pharmacovigilance and risk management with: Experience producing aggregate safety reports and signaling activities; Knowledge of applicable safety regulations, including clinical trials
• Strong Microsoft Excel, Word, and PowerPoint skills
• Advanced written and verbal communication skills
• Demonstrated ability to effectively balance multiple competing priorities and drive tasks forward in a fast-paced, global environment
• Proven success in cross-functional collaboration
• Strong capability to analyse data from a wide range of sources

Travel and Location

• Hybrid (2-3 days recommended) in the Boston office preferred
• Rare travel to France headquarters is possible