Servier Pharmaceuticals
Associate Director, Global Safety Lead
Servier Pharmaceuticals, Boston, Massachusetts, us, 02298
Associate Director, Global Safety Lead – Servier Pharmaceuticals, Boston, MA
The Associate 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.
Responsibilities
Coordinate 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
Support 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 database 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.
Help develop and update SOPs, Forms, Operating Manuals, and document templates related to safety activities.
Provide guidance and support to newly hired Global Safety staff/trainees/apprentices or external service providers.
Assist with audits and inspections, as needed.
Support initiatives outside of the assigned projects/compounds, as needed
Education and Required Skills
Medical Doctor (MD) or PharmD required with a minimum of 8 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
Nearest Major Market: Boston
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
#J-18808-Ljbffr
The Associate 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.
Responsibilities
Coordinate 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
Support 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 database 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.
Help develop and update SOPs, Forms, Operating Manuals, and document templates related to safety activities.
Provide guidance and support to newly hired Global Safety staff/trainees/apprentices or external service providers.
Assist with audits and inspections, as needed.
Support initiatives outside of the assigned projects/compounds, as needed
Education and Required Skills
Medical Doctor (MD) or PharmD required with a minimum of 8 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
Nearest Major Market: Boston
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
#J-18808-Ljbffr