Pharmacovigilance and Patient Safety Manager

at  WEP Clinical

Job Title: Pharmacovigilance and Patient Safety Manager
Location: Remote (UK/Ireland/EU-wide)
Status: Full-Time, Permanent
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.
WEP Clinical is a market leader in Expanded Access Programs (EAP) and post-approval Named Patient Programs. Our team of experts has over 15 years of experience and has distributed medicines in over 120 countries worldwide.
The WEP Clinical Pharmacovigilance and Patient Safety Manager is responsible for managing the safety profile of new drugs, devices, and various interventions in clinical trials, as well as during the post-marketing phase and in different types of expanded access programs. The Pharmacovigilance and Patient Safety Manager oversees safety matters related to study and program patients, handling all case-processing activities throughout all phases of drug development and in the post-marketing context.

QUALIFICATIONS

• 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.

MORE ABOUT US

WEP Clinical is a specialist services company that partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over a decade of experience distributing products worldwide to treat unmet patient needs. Our services include: Expanded Access Programs (EAPs), Named Patient Programs (NPPs), Clinical Trial Supplies (Comparator & Ancillaries), Wren Nursing (Clinical Trial Home Nursing & Clinical Education) and Hospital Supply of Unlicensed Medicines.

• Monitor activities of CROs/business partners to ensure adherence and compliance with applicable Safety Monitoring Plans, other study plans, metrics, KPIs and contractual agreements.
• Serve as SME/lead for PV compliance, inspection, and audit readiness for all Argus, KPIs, and safety management-related topics.
• Provide operational leadership for ICSR workflow, oversee the case management activities in Argus (or any other safety database used in the specific project) and ensure critical timelines and compliance are met.
• Provide pharmacovigilance oversight and support for ongoing clinical trials, post-market surveillance and expanded access programs to ensure integration of safety data collection, review, processing, and reporting.
• Responsible for peer review of cases in the safety database for quality control, adverse event coding review (using MedDRA and WHO drug), keeping report tracking and overseeing regulatory reporting activities, as required.
• Perform triage of incoming cases (assessing seriousness, expectedness, and causality), as required.
• Author high quality case narratives and collaborate on the development of analyses of similar events for the medical review of ICSR’s including identifying relevant information from source documents.
• Be familiar and up-to-date with regulatory requirements for safety management of Expanded Access Programs (EAPs) / Compassionate Use Programs (CUPs) in countries where WEP Clinical provides safety services.
• Produce accurate safety reports (i.e., CIOMS/MedWatch Forms) for submission to regulatory authorities and be accountable for complying with regulatory timelines.
• Provide support to the commercial team by joining client calls, writing proposals, reviewing budgets and presenting at bid defense meetings.
• Oversee the reconciliation of the safety and clinical databases for serious adverse events, collaborate with data management and other stakeholders and follow up with sites to resolve discrepancies, as needed.
• Act as system administrator for WEP Clinical’s global safety database (Argus), including providing vendor oversight to the Argus cloud hosting provider, support for issue resolution, maintenance of safety database libraries, initiation of change control, system testing, as applicable and training.
• Conduct active case follow-up, including safety queries generation and written and verbal follow-up with clinical investigators and sites.
• Author/ review Safety Management Plans and related forms (SAE form, pregnancy form, AESI form, etc.) and facilitate activities during project/study start-up phase, including cross-functional interactions.
• Collaborate with Medical Monitors, Clinical Operations, Regulatory Affairs, Data Management and other functional areas both internally and externally.
• Review, update and maintain Data Entry Conventions as applicable.
• Generate and/or support the preparation of periodic safety reports (e.g., DSUR, PSUR, PADER) in accordance with regulatory requirements and standard operating procedures.
• Support signal detection and evaluation activities in accordance with SOPs and guidelines.
• Provide safety content review of protocols, study reports, Investigator Brochure, informed consent and other related documents, as applicable.
• Develop and updated QA-controlled documents (e.g., SOPs, WIs, templates), as required.