Patient Safety and Pharmacovigilance Specialist

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives

The WEP Clinical Patient Safety & Pharmacovigilance Specialist is responsible for executing International Adverse Event and pharmacovigilance activities as required by Regulatory Agency regulations. The Patient Safety & Pharmacovigilance Specialist coordinates Adverse Event and pharmacovigilance activities for sites worldwide, provides support, training, and oversight in related Drug Safety activities including Product Quality complaints and Medical Information activities.

The Ideal Candidate

• Analytical
• Adaptable
• Detail Oriented
• Quality-focused

What You'll Do

• Monitor the Pharmacovigilance (PV) System through development of monthly performance reports to ensure regulatory compliance and process effectiveness.
• Prepare and analyze periodic PV metrics including KPIs, quality incidents, CAPAs, audits, and inspection outcomes.
• Compile and trend compliance data, conduct root cause assessments, gap analyses, and evaluate effectiveness of corrective actions.
• Evaluate safety reports and study documents for completeness, accuracy, and clinical relevance.
• Support audit and inspection readiness, and assist during internal audits and health authority inspections.
• Provide training on adverse event reporting and participate in internal and external meetings as needed.
• Manage safety mailbox, assess adverse event reports, and coordinate medical evaluations and escalations.
• Collaborate with cross-functional teams to enhance PV compliance activities across the organization.
• Author Safety Monitoring Plans and process adverse events in Argus database per regulatory and client requirements.
• Review and submit safety reports to regulatory agencies, resolve queries, and maintain adverse event ...

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