The Pharmacovigilance Scientist/Medical Writer provides functional area and operational support of assigned developmental and/or marketed product(s). He/She collaborates closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks, writes safety-related reports (DSURs, PBRERs, PADERs, RMPs), performs signal surveillance activities, and contributes safety information to regulatory submissions.
Demonstrates strong ability to communicate effectively in a matrix environment
Exhibits ability to multi-task effectively
Ability to complete work in a resourceful, self sufficient manner while maintaining a strong mentality
Demonstrates solid written and oral communication skills and sound attention to detail
Ability to analyze, interpret, and summarize moderately complex data with general oversight
Exhibits firm comprehension of established procedures
Applied understanding of industry practices for drug development and pharmacovigilance
Demonstrates awareness of related disciplines and an understanding of general concepts and experiential detail within those areas
Possesses computer skills to support use of electronic systems and development of writing deliverables
Prepares aggregate safety reports (PSURs, DSURs, PADERs), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks.
Supports Disease-area Safety Teams through meeting preparation and conduct, signal detection/tracking, preparing and maintaining Development RMP/RMP, and other risk management activities
Plans and reviews literature search results
Liaises with other functions to coordinate timely and appropriate submission of aggregate safety reports
Participates in departmental development activities including SOP and Work Instruction development, Audits and Inspections
PREFERRED EDUCATION AND EXPERIENCE
PharmD, PhD, MPH, advance healthcare degree, or equivalent professional experience
Minimum of 3 years pharmacovigilance or relevant experience, with data analysis and medical/scientific writing; preference for aggregate/periodic safety report preparation
Associated topics: ascp, lab, medical laboratory science, mls, mlt, molecular, technician iii, technician iv, technician laboratory, testing
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.