Pharmacovigilance Scientist

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.

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)

Requirements

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

Benefits

annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical, dental, and vision insurance; 401k match; flexible time off; paid holidays including year-end shutdown