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 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 out our 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 individuals who 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/   How to Apply: To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.    Important Note: To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page. 

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.