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: - PharmD, 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
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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;
or select 2.
Hybrid : work remotely up to two days per week;
or select 3.
On-Site : work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information 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 [click to reveal email address]
[email protected]
Job Tags
Full time, Summer work, Work at office, Remote work, Flexible hours, 2 days per week,