Manager, Drug Safety

Servier Monde • Boston, MA

238d

About The Position

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

Requirements

• Bachelor's degree in medical or other relevant life sciences required; PharmD strongly preferred
• 3+ years experience in pharmacovigilance/drug safety (Pharmaceutical Industry) with PharmD; 6+ experience with a Bachelor's degree
• Medical/clinical knowledge and familiarity with the oncology therapeutic area
• Proficient with the ARGUS safety database and regulatory reporting tools
• 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

Responsibilities

• Ensure the receipt, evaluation and processing post-marketing safety information obtained from all sources (spontaneous, solicited, literature, regulatory, etc.) for the assigned products
• Ensure that accurate and complete cases are sent to Global Safety within the timeframes established in PHARMA-SOP-005
• Responsible for all 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
• Manage safety reconciliations with internal departments, with partners and vendors
• Participates in maintaining quality documents (SOPs, OPMs, Work Instructions)
• Continuously assess and improve drug safety processes and systems within the organization
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree