MA Licensed Medical Safety Manager

A company is looking for a Remote Manager / Sr. Manager, Medical Safety and Risk Management (MSRM) PV Case Management.

Key Responsibilities :

Organize and manage resources for the capture and management of individual safety reports in compliance with global safety regulations

Ensure training and enforce procedures related to the collection, processing, and reporting of events from clinical trials and marketed sources

Collaborate with internal teams and vendors to establish and monitor key performance indicators (KPIs) relevant to safety data reporting

Required Qualifications :

Health care professional (e.g., RN, pharmacist) or other life sciences BS / BA preferred

Minimum of 5 years of relevant drug safety / pharmacovigilance experience

Extensive knowledge and experience with MedDRA and WhoDD coding dictionaries

Experience with software-based drug safety systems (ARGUS, ARISg, or equivalent)

Advanced knowledge of US and EU pharmacovigilance regulations for development and marketed products