Global Patient Safety & Pharmacovigilance Specialist

WEP Clinical; California; Hybrid; USD 110,000 - 160,000; Full time

Job summary

WEP Clinical is seeking a Patient Safety & Pharmacovigilance Specialist to lead international AE and PV activities, ensuring regulatory compliance across sites. You will train staff, coordinate medical evaluations, and enhance PV processes in collaboration with cross-functional teams.

The role requires a strong background in drug safety, ICH guidelines, and experience with Argus, delivering timely safety reports and supporting inspections.

Qualifications

• 3+ years’ experience in drug safety / pharmacovigilance in CRO or pharma industry.
• Experience in Clinical Trials and drug development (phases 1-4).
• Effective verbal and written communication skills.
• Working knowledge of FDA regulations and ICH guidance.
• Strong organizational skills and attention to detail.
• Ability to work in a fast-paced environment with changing priorities.

Responsibilities

• Monitor PV System with monthly performance reports for regulatory compliance and process effectiveness.
• Prepare and analyze PV metrics including KPIs, quality incidents, CAPAs, audits, and inspections.
• Compile trend data, conduct root cause analyses, gap analyses, and assess corrective actions.
• Evaluate safety reports and study documents for completeness and relevance.
• Support audit and inspection readiness, and assist during internal audits and health authority inspections.
• Provide training on adverse event reporting and participate in meetings.
• Manage safety mailbox, assess adverse events, and coordinate medical evaluations.
• Collaborate with cross-functional teams to enhance PV compliance across the org.
• Author Safety Monitoring Plans and process AE in Argus per regulatory/client requirements.
• Review and submit safety reports to regulatory agencies and maintain AE logs.
• Conduct literature reviews for AE identification and reconcile AE with partners.
• Serve as PV SME, support business development, train and oversee staff, assist onboarding.

Skills

Analytical

Adaptable

Detail Oriented

Quality-focused

Argus Safety Database

Microsoft Office

Education

Bachelor’s degree in medical, nursing, pharmaceutical, or life sciences

Advanced degree (BPharm, PharmD, RN, MD, MSc) preferred

Tools

Argus Safety Database

Microsoft Office

Job description

WEP Clinical is seeking a Patient Safety & Pharmacovigilance Specialist to lead international AE and PV activities, ensuring regulatory compliance across sites. You will train staff, coordinate medical evaluations, and enhance PV processes in collaboration with cross-functional teams.

The role requires a strong background in drug safety, ICH guidelines, and experience with Argus, delivering timely safety reports and supporting inspections.