Duration : 6-month contract

Location : Onsite in Waltham - 3 days onsite, 2 days wfh

Start 2 weeks from an offer

Responsibilities :

• 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.
• 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., RPh / PharmD, BSN, RN)
• 3-5 years drug safety or clinical safety experience
• Two years clinical experience in a medical setting, demonstrated general medical and pharmacology knowledge

Last updated : 2024-04-29