The Sr Pharmacovigilance Scientist/Medical Writer provides functional area and operational expertise 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, write safety-related reports (DSURs, PBRERs, PADERs, RMPs), perform signal surveillance activities, and contribute safety information to regulatory submissions.
* Demonstrates 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 and communicate those 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
* 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 signal evaluation reports, and other risk management activities
* Plans and executes literature surveillance
* Liaises with other functions to coordinate timely and appropriate submission of aggregate safety reports
* Provides leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high quality safety reports.
Minimum Qualifications :
* PharmD, PhD, MPH, advance healthcare degree, or equivalent professional experience
* Minimum of 5 years pharmacovigilance or relevant experience, including at least 2 years' concentration on aggregate safety report writing and 2 years' direct experience as a project manager on key projects or initiatives
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.