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 CROs and business partners for compliance with Safety Monitoring Plans, study plans, metrics, KPIs, and contractual agreements Lead pharmacovigilance (PV) compliance, inspection, and audit readiness for Argus, KPIs, and safety management topics. Oversee ICSR workflow, case management activities in Argus (or other safety databases), ensuring critical timelines and compliance Provide pharmacovigilance oversight for clinical trials, post-market surveillance, and expanded access programs, ensuring integration of safety data Perform peer review of cases in safety databases, including adverse event coding, report tracking, and regulatory reporting as needed Triage incoming cases, assess seriousness, expectedness, and causality, and write high-quality case narratives for medical review Stay updated on regulatory requirements for safety management in Expanded Access and Compassionate Use Programs (EAPs/CUPs) Produce and submit safety reports (e.g., CIOMS/MedWatch Forms) to regulatory authorities, ensuring compliance with timelines Support the commercial team by participating in client calls, reviewing proposals, budgets, and presenting at bid defense meetings Act as system administrator for WEP Clinical's global safety database (Argus), overseeing vendor relationships, system maintenance, and training 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 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.
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Diligent Analytical Proactive What You'll Do:
Monitor CROs and business partners for compliance with Safety Monitoring Plans, study plans, metrics, KPIs, and contractual agreements Lead pharmacovigilance (PV) compliance, inspection, and audit readiness for Argus, KPIs, and safety management topics. Oversee ICSR workflow, case management activities in Argus (or other safety databases), ensuring critical timelines and compliance Provide pharmacovigilance oversight for clinical trials, post-market surveillance, and expanded access programs, ensuring integration of safety data Perform peer review of cases in safety databases, including adverse event coding, report tracking, and regulatory reporting as needed Triage incoming cases, assess seriousness, expectedness, and causality, and write high-quality case narratives for medical review Stay updated on regulatory requirements for safety management in Expanded Access and Compassionate Use Programs (EAPs/CUPs) Produce and submit safety reports (e.g., CIOMS/MedWatch Forms) to regulatory authorities, ensuring compliance with timelines Support the commercial team by participating in client calls, reviewing proposals, budgets, and presenting at bid defense meetings Act as system administrator for WEP Clinical's global safety database (Argus), overseeing vendor relationships, system maintenance, and training 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 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.
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