Pharmacovigilance Scientist

Replimune•Woburn, MA

2d•$137,500 - $178,000•Onsite

About The Position

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.

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

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)