Patient Safety and Pharmacovigilance Specialist
Job description
The Patient Safety & Pharmacovigilance Specialist executes international adverse event and pharmacovigilance activities as required by regulatory agencies, coordinating these activities for sites worldwide and providing support, training, and oversight in drug safety activities including product quality complaints and medical information.
At a glance
- Work mode
- Remote · Canada
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 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
What we're looking for
- A Bachelor's degree in a medical, nursing, pharmaceutical, or life sciences discipline is required
- 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
Nice to have
- An advanced degree (e.g., BPharm, PharmD, RN, MD, MSc, or equivalent) is strongly preferred
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About WEP Clinical
WEP Clinical provides end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, offering 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, they have supported programs across 150+ countries.
Mission
WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most.
Key facts
- Clinical research / biopharmaceutical services
- More than 15 years of global experience
- Supported programs across 150+ countries
- Services include Access Programs, Clinical Trial Services, Patient Site Solutions, Clinical Trial Supply, Market Access and Commercialization
What they value
- Integrity
- Accountability
- Respect for diverse perspectives
- Innovation
- Collaboration