[Hiring] Patient Safety and Pharmacovigilance Specialist @WEP Clinical

Role Description

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.

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.

Qualifications

• A Bachelor’s degree in a medical, nursing, pharmaceutical, or life sciences discipline is required; an advanced degree (e.g., BPharm, PharmD, RN, MD, MSc, or equivalent) is strongly preferred
• 3+ years’ experience in drug safety / pharmacovigilance in the CRO or pharmaceutical industry
• Experience in Clinical Trials and drug development (phases 1-4)
• Effective verbal and written communication skills
• Working knowledge of Argus Safety Database
• Computer literacy and proficient in Microsoft Office, particularly Word, Excel, PowerPoint
• Familiar with FDA regulations and ICH guidance
• Strong organizational skills and attention to detail
• Must possess the ability to work effectively in a fast-paced environment, and deal effectively with changing priorities

Requirements

• 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 logs.
• Conduct literature reviews for adverse event identification, reconcile AE reports with partners, and manage product complaints.
• Serve as a PV subject matter expert, support business development, train and oversee staff, and assist with resource onboarding.

Benefits

• WEP has many initiatives to encourage wellness, growth and development, and team relationships.
• Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees.

Company Description

WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.