Note: The job is a remote job and is open to candidates in USA. Vertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation. The Patient Safety Pharmacovigilance Sciences Manager will be responsible for the preparation of aggregate safety reports and will collaborate with Patient Safety Physicians on product safety teams to support risk management activities.
Responsibilities
Contributes to PV Sciences activities for Vertex products, marketed or in any phase of development
Prepares aggregate safety reports, including establishment of timelines, content and project management, safety database report requests, review of data, and compilation of information
Supports Disease-area Safety Team (DAST) through meeting preparation and conduct, signal detection/tracking, RMP development and maintenance, and other risk management activities
Conducts literature search results in collaboration with the Patient Safety Physician for identification of potential safety issues/signals and inclusion in aggregate safety reports
Collaborates with Regulatory Affairs and other functions to coordinate submission of aggregate safety reports
Collaborates with Quality, Standards & Training to ensure aggregate safety report procedures, training, and activities are sufficiently defined and maintained.
Participates in departmental development activities including SOP and Work Instruction development, Audits and Inspections.
Performs other duties as assigned
Skills
Typically requires 3 years of experience in pharmacovigilance or relevant experience with, data analysis and medical/scientific writing
Demonstrates strong ability to communicate effectively to exchange complex information with others
Exhibits ability to multi-task effectively
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
Applies good understanding of industry practices for drug development and PV
Demonstrates basic knowledge 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
Education Requirements
PharmD, PhD, MPH, advanced healthcare degree, or equivalent professional experience
Benefits
Annual bonus
Annual equity awards
Overtime pay
Medical, dental and vision benefits
Generous paid time off
Educational assistance programs including student loan repayment
Generous commuting subsidy
Matching charitable donations
401(k)
Company Overview
Vertex Pharmaceuticals is focused on the discovery and development of small molecule drugs for the treatment of serious diseases. It was founded in 1989, and is headquartered in Boston, Massachusetts, USA, with a workforce of 5001-10000 employees. Its website is http://www.vrtx.com.
Company H1B Sponsorship
Vertex Pharmaceuticals has a track record of offering H1B sponsorships, with 151 in 2025, 150 in 2024, 111 in 2023, 164 in 2022, 112 in 2021, 80 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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