Senior Drug Safety Associate

Princeton, NJ 08540

Posted: 09/18/2019 Industry: Biotech/R&D/Science Job Number: 49547

Position Summary: The Senior Drug Safety Associate is responsible for assigned  Pharma  Risk Evaluation and Mitigation Strategy (REMS) programs  and for other  Pharmacovigilance activities as detailed below.

The responsibilities of this role include, but are not limited to the following:

Participate in REMS  meetings and manage the development, implementation and/or maintenance  of REMS
  • Timely escalate issues related to vendor performance, compliance and/or budget to Manager
  • Ensure timely execution of operational aspects of REMS and related activities
  • Review all REMS related documentation and approve as required
  • Monitor external environment for regulatory changes impacting Pharmacovigilance and  risk management
  • Ensure audit preparedness and support regulatory inspections
  • Identify and lead process improvement activities
  • Assist with regulatory submissions
  • Assist with performing follow ups for ADEs as required
  • Support training management
  • Support compliance driven initiatives

Qualifications:

Bachelor’ s degree preferably in a scientific discipline. 1 to 3 years of experience in Pharmacovigilance within the pharmaceutical industry with experience in REMS or other risk management strategies preferred. Experience managing a vendor (e.g. CRO, REMS administrator) and managing  project timelines.

Skills:

Excellent interpersonal skills and effective communication skills
Adapts to changing circumstances and effectively prioritizes workload according to business need
Ability to multi-task and manage projects simultaneously assuring compliance
Working knowledge of FDA, Health Canada and/or EMEA regulations/guidances/guidelines  with respect to Pharmacovigilance and REMS
  Proficient in Microsoft Word, Excel, PowerPoint, SharePoint, Adobe Acrobat

Melissa Valazza

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