Pharmacovigilance Scientist

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 communication skills, strong attention to detail, and high performance standards for quality Ability to analyze, interpret, and summarize complex clinical and medical literature data Ability to prioritize and complete work in a resourceful, self-sufficient manner while maintaining a strong mentality Displays ability to understand established procedures to others Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance Demonstrates awareness of related medical disciplines and an understanding of general concepts and some experiential detail within those areas Processes computer skills to support use of electronic systems and development of writing deliverables Salary Range Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $137,500-178,000. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer. At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit We are an Equal Opportunity Employer. #J-18808-Ljbffr