Sr. Spclst, Drug Safety
Core
Managing company relationships with business development partners, third-party vendors, and CROs to ensure compliance with global pharmacovigilance regulations and maintain high-quality safety reporting.
Role type
Senior Specialist, Pharmacovigilance Partner Strategy & Management
Builds
PV agreements, safety management plans (SMPs), and vendor compliance frameworks
Domain
Pharmaceutical industry, Drug Safety, Regulatory Compliance
Deliverable
client delivery
Required skills
Pharmacovigilance principles, Pharmacovigilance regulations, Adverse Event Report management, Auditing, Compliance Monitoring, Partnership Strategy, Drug Safety Surveillance, Regulatory Reporting, Risk Management, Business Processes
Preferred skills
Clinical Risk Management, Life Sciences background, Strategic Planning, Training and Development
Responsibilities
Negotiate and maintain PV agreements and SMPs with partners and vendors; Lead due diligence and compliance reviews of third-party vendors; Develop and maintain processes for individual and aggregate safety reporting; Facilitate meetings for PV agreement implementation; Support inspections and audits related to partnerships.
Seniority
Senior, hands-on IC
