The Operations Specialist 2 is responsible for end‑to‑end processing and oversight of Safety data, applying in‑depth pharmacovigilance expertise and complex decision‑making
Job Summary
The Operations Specialist 2 is responsible for end‑to‑end processing and oversight of Safety data, applying in‑depth pharmacovigilance expertise and complex decision‑making.
Key responsibilities include performing full‑service processing of Safety cases, collecting, tracking, assessing, and processing Adverse Events (AEs), and generating, tracking, and submitting regulatory reports.
This role also involves mentoring and training junior team members, contributing to training initiatives and process improvements, and participating in audits and continuous improvement initiatives.
Matching Summary
The Operations Specialist 2 is responsible for end‑to‑end processing and oversight of Safety data, applying in‑depth pharmacovigilance expertise and complex decision‑making.
Skills & Requirements
Must-have
Safety case processing
Adverse Event (AE) processing
Safety databases (e.g., Argus Safety)
Global pharmacovigilance regulations
End-to-end safety data oversight
Nice-to-have
Subject matter specialist
Cross-functional team collaboration
Continuous improvement initiatives
Mentoring junior team members
Key Requirements
Bachelor's degree in Life Sciences, Healthcare, or related field
At least 3 years of Pharmacovigilance experience
Experience with clinical trials and post-marketing exposure