What are the responsibilities and job description for the Drug Safety Manager position at Talent Groups?
Need Independent candidates only (USC/ GC).
The Senior Manager, PV Operations will support global drug safety activities across clinical development and post-marketing programs.
Minimum 5 years of biotech/pharma experience, including 3 years in drug safety/ Pharmacovigilance.
Experience with CRO/vendor oversight, global PV operations, and strong knowledge of FDA, EU, and ICH guidelines required.
Reporting to the Director of PV Operations, this role oversees case processing performed by external vendors, ensuring all activities meet regulatory requirements, internal SOPs, and industry best practices.
The Senior Manager leads daily PV operations, supports SAE reporting and reconciliation, ensures compliant safety data exchange, and monitors vendor performance through KPIs and oversight reports.
Bachelor’s degree in nursing, pharmacy, life sciences, or related field.
