Servier Pharmaceuticals
Associate Director, Global Safety Lead
Servier Pharmaceuticals, Boston, Massachusetts, us, 02298
Overview
Associate Director, Global Safety Lead role at Servier Pharmaceuticals. The position is part of the Global Safety organization, collaborating with Global Safety Leads based in Boston, MA (USA) or Suresnes, France. The role supports safety and risk management activities for assigned development and marketed compounds in line with internal procedures and regulatory requirements. About Servier
Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision. Primary Responsibilities
Coordinate signal detection activities, including kickoff activities, planning, safety data retrieval and analysis, and authoring some sections of Safety Evaluation Reports (SER) or Development Safety Evaluation Reports (DSER) for development and marketed compounds. Generate and coordinate aggregated safety reports (including PBRER, PSUR, PADER, DSUR, INDAR, 6-month line-listings, etc.), for development and marketed compounds, including contribution to kickoff activities, planning, data analysis, and authoring of sections and validation of appendices. Support the coordination of risk evaluation and mitigation activities for development and marketed compounds, including analysis of safety data and authoring of some sections (e.g., Development Risk Management Plan, RMP, REMS). Prepare and review safety sections of documents (concept sheets, protocols, ICF, CSR) and participate in CRF AE/SAE page validation and User Acceptance Testing. Conduct safety reviews and perform periodic quality checks of vendor-generated 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 (clinical and post-marketing commitments). Represent the Medical Safety Division in project teams and study teams as required. Maintain and update safety sections of the CCDS (CCSI) and datasheets related to 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, or external service providers. Assist with audits and inspections, as needed. Support initiatives outside of 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 and post-approval settings preferred Demonstrated knowledge of pharmacovigilance and risk management, including 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 Ability to balance multiple priorities and drive tasks forward in a fast-paced, global environment Proven success in cross-functional collaboration Strong ability to analyze data from diverse sources Travel and Location
Hybrid (2-3 days in the Boston office preferred) Rare travel to France headquarters is possible Servier’s Commitment
Servier is committed to modeling diversity, equity, and inclusion within the industry. We welcome applicants who are passionate, committed, and innovative. We encourage candidates to apply to open roles as we are always willing to consider experiences and skills beyond what is listed in the job description. 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. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research Industries: Pharmaceutical Manufacturing and Biotechnology Research
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Associate Director, Global Safety Lead role at Servier Pharmaceuticals. The position is part of the Global Safety organization, collaborating with Global Safety Leads based in Boston, MA (USA) or Suresnes, France. The role supports safety and risk management activities for assigned development and marketed compounds in line with internal procedures and regulatory requirements. About Servier
Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision. Primary Responsibilities
Coordinate signal detection activities, including kickoff activities, planning, safety data retrieval and analysis, and authoring some sections of Safety Evaluation Reports (SER) or Development Safety Evaluation Reports (DSER) for development and marketed compounds. Generate and coordinate aggregated safety reports (including PBRER, PSUR, PADER, DSUR, INDAR, 6-month line-listings, etc.), for development and marketed compounds, including contribution to kickoff activities, planning, data analysis, and authoring of sections and validation of appendices. Support the coordination of risk evaluation and mitigation activities for development and marketed compounds, including analysis of safety data and authoring of some sections (e.g., Development Risk Management Plan, RMP, REMS). Prepare and review safety sections of documents (concept sheets, protocols, ICF, CSR) and participate in CRF AE/SAE page validation and User Acceptance Testing. Conduct safety reviews and perform periodic quality checks of vendor-generated 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 (clinical and post-marketing commitments). Represent the Medical Safety Division in project teams and study teams as required. Maintain and update safety sections of the CCDS (CCSI) and datasheets related to 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, or external service providers. Assist with audits and inspections, as needed. Support initiatives outside of 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 and post-approval settings preferred Demonstrated knowledge of pharmacovigilance and risk management, including 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 Ability to balance multiple priorities and drive tasks forward in a fast-paced, global environment Proven success in cross-functional collaboration Strong ability to analyze data from diverse sources Travel and Location
Hybrid (2-3 days in the Boston office preferred) Rare travel to France headquarters is possible Servier’s Commitment
Servier is committed to modeling diversity, equity, and inclusion within the industry. We welcome applicants who are passionate, committed, and innovative. We encourage candidates to apply to open roles as we are always willing to consider experiences and skills beyond what is listed in the job description. 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. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research Industries: Pharmaceutical Manufacturing and Biotechnology Research
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