Job Title: Clinical Patient Safety and Pharmacovigilance Manager (GCP focused)
Location: Remote (UK only)
Permanent+Full time
Client Overview
Peritia is a Career Portfolio Management company supporting companies in drug, device, and biologic development, is supporting a CRO with Pharmacovigilance oversight activities. Our client is focused on working with Sponsors to help advance their much-needed medicines and get them to patients worldwide.
Role Objectives:
The Clinical Patient Safety and Pharmacovigilance Manager is responsible for managing the safety profile of new drugs, devices and any type of interventions in clinical trials, in the post-marketing phase and in different types of expanded access programs. The PV & PS Manager oversees study/ program patients’ safety matters, all case-processing activities through all phases of drug development and in the post-marketing setting. It is their responsibility to provide regulatory reporting and support to medical monitoring tasks and work closely with other departments, sponsors and investigators to ensure that all plans and processes are in place to appropriately collect and report information on adverse events (AE) and Serious Adverse Events. Additionally, it is their responsibility to assist the Medical Affairs Department leadership in managing the relevant activities of the safety group, and providing scientific/clinical expertise in management of clinical and post-marketing Individual Case Safety Reports (ICSRs), management of SAE reconciliation activities, vendor management of relevant activities and PV compliance.
Principal Duties and Responsibilities:
* 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 and 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 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 Clinical business development team by joining client calls, writing proposals, reviewing budgets and presenting on bid defenses 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 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.
* Responsible for the line management of pharmacovigilance staff including leadership, oversight, training, mentoring and development.
* Support other pharmacovigilance activities, as needed.
Qualifications: Bachelor’s Degree in a Science or related field required; advanced degree (PharmD, MD, etc.) strongly preferred.
* 5+ years’ experience in drug safety, pharmacovigilance in a clinical trial setting, preferably in the biotech, pharmaceutical industry and/or in a CRO.
* 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.