Drug Safety Specialist

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. 

Role Summary 

The Drug Safety Specialist (DSS) is part of the Medical Affairs Group and reports to the Head of Local Pharmacovigilance (LPV). As Deputy LPV (dLPV), the DSS will also have a functional link with the EEA QPPV (dotted line manager). The DSM will interact with employees from various Servier departments and with HCPs, service providers, or consumers. The key goal of the DSS include creation of accurate and complete post-marketing individual case safety reports (ICSRs) and their transmission to Global Safety in accordance with the internal timelines, thus contributing to ensuring compliance with the regulatory requirements for post-marketing safety surveillance for the assigned products. Being involved in managing the safety information for various products and from various sources make this role challenging and exciting. 

Primary Responsibilities 

• Receipt, evaluation and processing post-marketing safety information obtained from all sources (spontaneous, solicited, literature, regulatory, etc.) 

• Ensure that accurate and complete cases are sent to Global Safety within the timeframes established in PHARMA-SOP-005 

• Direct contact with healthcare professionals, consumers, and service providers in order to obtain details on the reported PV information where necessary, as well as follow-up information as needed 

• Participates in reconciliations with internal departments, with partners and vendors 

• Participates in maintaining quality documents (SOPs, OPMs, Work Instructions) 

• Stay current with global pharmacovigilance regulations, industry trends, and safety-related developments. 

• Other dLPV duties as described in PHARMA-SOP-106 or as directed by the functional management. 

Education and Required Skills 

• Medical or other relevant life science degree or experience as health care professional  

• 1-3+ years of experience in pharmacovigilance/drug safety (Pharmaceutical Industry) 

• Medical/clinical knowledge and familiarity with the oncology therapeutic area 

• Experience with the ARGUS safety database  

• High ethical standards and strict sense of confidentiality 

• Excellent communication and interpersonal skills, both written and verbal. 

• Strong attention to detail, organizational, and project management skills. 

• Ability to work effectively under pressure and meet tight deadlines. 

Travel and Location 

• Minimal travel required  

• Preferred Boston hybrid (office presence 2-3 days a week) 

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.