Job Description:

Duration: 6-month contractLocation: Onsite in Waltham - 3 days onsite, 2 days wfhStart 2 weeks from an offerResponsibilities: Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA, Alkermes SOPs, and applicable licensing or partnership agreements.Acts as a safety representative and facilitator between external reporting sources such as call centers, CROs and investigator sites, interface with internal departments clinical operations, medical information, regulatory affairs, product development, quality assurance, biostatistics, data management, and legal.Participate in clinical project teams and other interdepartmental teams supporting clinical studies; reviews and provide comments on study related documents.Contributes to the development and writing of industry standard operating procedures and processes for pharmacovigilance activities including writing of the Safety Management Plan for assigned studies to ensure the uniform and timely processing of adverse event reports.Assist in responding to queries from health authorities or outside sources; Compiling and supplying as requested, safety information for Regulatory submissions such as IND (Investigational New Drug) safety reports, Annual Safety reports, PSUR, or clinical study reports.Qualifications: A clinical degree (e.g., RPhPharmD, BSN, RN)3-5 years drug safety or clinical safety experienceTwo years clinical experience in a medical setting, demonstrated general medical and pharmacology knowledge