Director, Global Safety Lead

About Servier

With commercial stage products and a promising pipeline, we are a US-based affiliate of Servier Group, a unique global organization headquartered in France. Operating in more than 150 countries and governed by a non-profit foundation, we have multiple medicines approved in oncology, & other disease states globally. Additionally, we have accelerated our investments with an ambition to further establish ourselves as innovators in the Oncology space. Over half of our research and development efforts are specifically focused on delivering significant advances in targeted therapies to treat patient communities with unmet needs.  At Servier, you will join a highly skilled team dedicated to bringing the promise of tomorrow to the patients we serve.

Primary Responsibilities

• Contribute in safety and risk management activities of the assigned development or marketed compounds, in accordance with the internal procedures and regulatory guidelines.
• Contribute to the medical review, drug safety related activities associated with clinical development, signal detection and evaluation, aggregate reports writing, benefit-risk assessment, and safety risk management.
• Coordinate the signal detection activities, including kick off activities, planning, safety data retrieval and analysis, authoring of some sections of the Safety Evaluation Report (SER) or Development Safety Evaluation Report (DSER), etc. for development and marketed compounds.
• Coordinate and generate the aggregated safety reports for both for development and marketed compounds (Periodic Benefit Risk Evaluation Report (PBRER), Periodic Safety Update Report (PSUR), Periodic Adverse Drug Experience Report (PADER), Development Safety Update Report (DSUR), Investigational New Drug Annual Report (INDAR), 6 monthly line-listings, etc.), including contribution in set up of kick off activities, planning, safety data analysis, authoring of some sections, validation of appendices, etc.
• Review and generate safety sections of documents (concept sheets, protocols, Informed Consent Form (ICF), Clinical Study Report (CSR), etc.).
• Contribute to regulatory filings (New Drug Application (NDA), Supplemental New Drug Application (sNDA), Marketing Authorization Applications (MAA)) and in 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.
• Support maintenance of safety sections of the Company Core Data Sheet (CCDS) (Company Core Safety Information (CCSI)) and datasheets corresponding to the CCDS/CCSI/Reference Safety Information (RSI)/Investigators Brochure (IB) or local Product Information (PI).

Education and Required Skills

• Must have a Medical Doctor (MD) or Doctor of Pharmacy (PharmD) (or foreign equivalent).
• Must also have:
  • 7 years of experience as a safety physician / scientist.
  • Experience with contributing to medical review, drug safety related activities associated with clinical development and post-marketing setting, signal detection and evaluation, aggregate reports writing, benefit-risk assessment, and safety risk management.
  • Experience with reviewing and generating safety sections of documents (concept sheets, protocols, ICF, CSR, etc.) as well as Case Report Form (CRF) adverse event/serious adverse event (AE/SAE) page validation and participation in User Acceptance Testing (UAT).
  • Experience with contributing to regulatory filings (New Drug Application (NDA), Supplemental New Drug Application (sNDA), Marketing Authorization Application (MAA)) and in Health Authority queries or interactions (covering clinical and post-marketing commitments).
  • Experience may be gained concurrently

Travel and Location

• Position eligible for telecommuting part of the time from within commuting distance of the Boston office.
• International travel required less than 10% of the time.
• Monday-Friday, 9:00 a.m. – 5:00 p.m
• Apply to Servier Bio-Innovation LLC at: jobs.servier.com

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our 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.

Salary Range

The salary range for this role is $195,458.00 - $289,576.30. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).  For more information on our benefits, please visit this link.