Patient Safety and 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

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 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 You’ll Need

• 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

What Sets Us Apart

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.

We're Committed to Our Team

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

How We Work at WEP Clinical

At WEP Clinical, we look for individualswho are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

Our Services Include

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialization

Data Privacy Notice

WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.

Privacy Policy: https://www.wepclinical.com/privacy-policy/

Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/

For Your Safety, Please Note

We will never communicate with you via Microsoft Teams or text message.

We will never ask for your bank account information at any stage of recruitment.

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.