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 We Offer:

Medical, dental, and vision insurance, FSA, HSA

Voluntary short-term and long-term disability insurance

Voluntary life insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid maternity & paternity leave

What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

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 that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialization

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.