Pharmacovigilance Sciences Manager; Remote

Pharmacovigilance Sciences Manager (Remote) page is loaded## Pharmacovigilance Sciences Manager (Remote) locations: Boston, MAtime type: Full time posted on: Posted Todayjob requisition : REQ-26552

• * Job Description
• *** General Summary:
• * The Patient Safety Pharmacovigilance (PV) Sciences Manager will be responsible for the preparation of aggregate safety reports, including PSURs, PADERs, and DSURs, for assigned Vertex products, marketed or in development. The PV Sciences Manager will collaborate closely with Patient Safety Physicians on product safety teams and in supporting risk management activities, including signal detection and tracking, Regulatory Authority requests, and maintenance of risk management plans (RMPs).
• * Key Duties and 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
• * Knowledge and Skills:
• ** 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 and Experience:
• ** Pharm D, PhD, MPH, advanced healthcare degree, or equivalent professional experience
• Typically requires 3 years of experience in pharmacovigilance or relevant experience with, data analysis and medical/scientific writing#LI-AR1#LI-Remote
• * Pay Range:**$120,000 - $179,900
• * Disclosure Statement:
• * The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
• * Flex Designation:
• * Remote-Eligible
• * Flex Eligibility Status:
• * In this Remote-Eligible role, you can choose to be designated as: 1.
• * Remote**: work remotely five days per week and come into the office on occasion – you’re always welcome on-site;… Apply To this Job

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