Global Safety Manager

Roles and Responsibilities :

• Work under the supervision of the Post Market Surveillance and Trending Lead to support safety vigilance for combination products and medical devices.
• Review regulatory updates from GPS PV Intelligence and evaluate their impact on Combination Product Safety (CPS).
• Perform literature searches and review findings related to applicable medical devices.
• Extract and analyze adverse event (AE) data from relevant databases to assess changes in post-product risk values.
• Pull and analyze external safety data from FDA MAUDE and FAERS databases.
• Evaluate correlations between product complaints (PC) and adverse events (AE) identified during monthly holistic reviews to assess potential patient and user safety risks.
• Reconcile lot-level AE excursions with PC excursions to support detailed trending analysis.
• Support post-marketing surveillance activities by collecting and analyzing safety data for combination products and medical devices.
• Prepare and provide metrics for governance forums and assist with audits and inspections as necessary.

Required Knowledge and Skills :

Preferred Knowledge and Skills :

Basic Qualifications :

Skills Required

Python, Power Bi