Pharmacovigilance Scientist at Replimune Group in Woburn

Job description

Overview Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. Reports to: Sr Director, Safety Risk Management & PV Sciences Summary of job description: PV Scientist will report to Sr Director, Safety Risk Management & PV Sciences and support the medical component of pharmacovigilance activities including: surveillance and monitoring activities providing scientific/clinical PV expertise with a focus on the identification, evaluation and management of safety risks for Replimune developmental and marketed products. PV Scientist will collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks. Key responsibilities: · Perform independently as well as collaboratively, all relevant safety data analyses needed for the Safety Management Team and Safety Committee meetings; ensure adequate documentation, distribution, and archiving of meeting minutes · Create and maintain an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection · Support other function teams for Replimune Investigational products; serve as PV expert and liaise with Clinical Operations, Biostatistics, Regulatory Affairs, Contract Research and other entities as needed · Contribute to health authority and other safety related query responses · Support study teams for Replimune investigational products; serve as PV expert and liaise with Clinical Operations, Medical Affairs · Support PV Medical team for MedDRA and WHO Drug coding review and post marketing case review · Lead post marketing case query preparation; closely work with PV compliance, PV operations and Medical Affairs · Become familiar with ARGUS safety database reporting tool and generate line listing to support PV medical team as needed · Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH) · Ensure compliance with Replimune and GVP&Risk Management policies and procedures · Support PV Medical for IB update, protocol update, eCRF preparation, and ICF preparation · Prepares aggregate safety reports (e.g.DSUR, PADER, PSUR), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks · Plans, executes, and documents all literature surveillance activities · Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high quality safety reports · Contribute SOP/WI preparation/update · Support BLA/MAA related and other PV activities such as Risk Management Plan/PV Plan creation and maintenance · Perform other duties as directed · Travel on site as required (e.g. site inspection, important meeting) Qualifications: • Pharm D, BSN, MD, PhD, MPH, advanced healthcare degree, or equivalent professional experience • Minimum 4 years pharmacovigilance or research experience • Thorough understanding of the drug development process and context applicable to safety surveillance activities • Knowledge of MedDRA terminology and its application • Knowledge of Clinical/Safety database • Excellent written and oral co