Drug Safety Specialist
Position Summary: The Senior Drug Safety Associate is responsible for assigned company's 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
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.
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
Sthree US is acting as an Employment Business in relation to this vacancy.