Job Description
Job Description
Job Description
Job Title: Pharmacovigilance and Patient Safety Manager
Job Location: United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Do you want to be a part of a team that gives hope to patients with rare and life-threatening diseases? Do you thrive in an innovative, growth-oriented environment? At WEP Clinical, we are looking for an experienced Pharmacovigilance and Patient Safety Manager interested in joining us in an exciting phase of high growth and helping us shape the future of clinical research.
Role Objectives The WEP Clinical Pharmacovigilance and Patient Safety Manager is responsible for managing the safety profile of new drugs, devices, and interventions in clinical trials, as well as during the post-marketing phase and across various expanded access programs. The Manager oversees all safety matters related to study and program participants, handling case-processing activities throughout all phases of drug development and in the post-marketing context.
The Ideal Candidate - Diligent
- Analytical
- Proactive
What You'll Do - Monitor CRO/business partner activities to ensure adherence to Safety Monitoring Plans, study plans, KPIs, and contractual agreements
- Serve as SME for PV compliance, inspection readiness, and safety management topics
- Provide operational leadership for ICSR workflows and oversee case management in Argus or other safety databases
- Ensure pharmacovigilance oversight for clinical trials, post-market surveillance, and Expanded Access Programs (EAPs)
- Perform case triage, quality control, and adverse event coding using MedDRA and WHO drug
- Author safety reports (e.g., CIOMS/MedWatch) and ensure compliance with regulatory timelines
- Collaborate with stakeholders for safety database reconciliation and resolve discrepancies
- Oversee global safety database administration, including vendor oversight, issue resolution, and training
- Author/review Safety Management Plans, study forms, and periodic safety reports (e.g., DSUR, PSUR)
- Support signal detection, evaluation activities, and provide safety content review for regulatory documents
What You'll Need - Bachelor’s Degree in a Science or related field required; advanced degree (PharmD, MD, etc.) strongly preferred
- Experienced in drug safety/pharmacovigilance role in the biotech/pharmaceutical industry and/or in a CRO or clinical trial setting
- Proficient with International Council for Harmonization (ICH) Good Clinical Practices (GCP) guidelines and other applicable regulatory rules and guidelines, as well with medical terminology, clinical trials and clinical research
- Familiarity with and ability to effectively utilize safety databases needed. Knowledge of Argus Safety Database in an administration capacity is preferred
- Action-oriented and resilient in a fast-paced environment with strong project team skills and ability to mentor, delegate and motivate others
- Ability to communicate effectively with clients, internal teams and vendors and soft skills to build and maintain trust and confidence
- Strong understanding of global safety regulations, medical terminology, and drug development process
- Strong clinical background, with ability to interpret medical records (e.g., laboratory results, medical records) is a plus
What We Offer Medical, dental, and vision insurance
Short-term disability insurance
Life insurance
Voluntary Long-term disability insurance
401K safe harbor plan and company match
Paid vacation, holiday, sick, and volunteer time
Paid maternity & paternity leave
Personal Development Allowance
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 Expanded Access Programs (EAPs)
Named Patient Programs (NPPs)
Clinical Trial Supplies (Comparator & Ancillaries)
Wren Nursing (Clinical Trial Home Nursing & Clinical Education)
Hospital Supply of Unlicensed Medicines
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. Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
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