Pharmacovigilance Sciences Manager (Remote)

Job DescriptionGeneral reputed company:The Patient Safety Pharmacovigilance (PV) Sciences Manager will be responsible for the preparation of aggregate safety reports, including PSURs, PADERs, and DSURs, for assigned reputed company 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 reputed company 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 reputed company, 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 assignedKnowledge and Skills:• Demonstrates strong ability to communicate effectively to exchange reputed company information with others• Exhibits ability to multi-task effectively• Demonstrates solid written and oral communication skills, and reputed company attention to detail• Ability to analyze, interpret, and summarize moderately reputed company data with general reputed company• Exhibits firm comprehension of established procedures• Applies good understanding of industry practices for drug development and PV• Demonstrates basic knowledge of reputed company disciplines, and an understanding of general concepts and experiential detail reputed company those areas• Possesses computer skills to support use of electronic systems and development of writing deliverablesEducation and Experience:• PharmD, PhD, MPH, advanced reputed company degree, or equivalent reputed company experience• Typically requires 3 years of experience in pharmacovigilance or relevant experience with, data analysis and medical/scientific writing#LI-AR1#LI-RemotePay reputed company: $120,000 - $179,900Disclosure Statement:The reputed company provided is based on reputed company reputed company is a reasonable estimate for the reputed company salary pay reputed company 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 reputed company salary pay will be based on a number of factors, including skills, competencies, experience, and other job-reputed company factors permitted by law.At reputed company, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing reputed company while providing flexibility and resources to support their reputed company and aspirations. From medical, dental and reputed company benefits to generous reputed company 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.reputed company Designation: Remote-EligibleFlex 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 select2. Hybrid: work remotely up to two days per week; or select3. On-Site: work five days per week on-site with reputed company flexibility.Note: reputed company status for this position is subject to reputed company's Policy on reputed company @ reputed company Program and may be changed at any time.Company InformationVertex is a global biotechnology company that invests in scientific innovation.reputed company is committed to equal employment opportunity and non-discrimination for reputed company and reputed company applicants without reputed company to a person's race, reputed company, sex, gender identity or reputed company, age, religion, national reputed company, reputed company, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. reputed company is an E-Verify Employer in the reputed company. reputed company will reputed company reasonable accommodations for reputed company individuals with reputed company disabilities, in accordance with applicable law.Any applicant requiring an accommodation in reputed company with the hiring process and/or to reputed company the essential functions of the position for which the applicant has reputed company should reputed company a request to the recruiter or hiring manager, or contact reputed company at ApplicationAssistance@vrtx.com Apply tot his job Apply To this Job