Pharmacovigilance Sciences Manager (Remote)

Role Summary

Pharmacovigilance Sciences Manager (Remote) responsible for preparation of aggregate safety reports (PSURs, PADERs, DSURs) for Vertex products, collaborating with Patient Safety Physicians on product safety teams and in risk management activities including signal detection, Regulatory Authority requests, and maintenance of risk management plans (RMPs).

Responsibilities

• Contributes to PV Sciences activities for Vertex products, marketed or in any phase of development
• Prepares aggregate safety reports, including timelines, content and project management, safety database report requests, data review, and information compilation
• 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 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 defined and maintained
• Participates in departmental development activities including SOP and Work Instruction development, Audits and Inspections
• Performs other duties as assigned

Qualifications

• 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

Skills

• Demonstrates strong ability to communicate effectively to exchange complex information
• Ability to multi-task effectively
• Solid written and oral communication skills with attention to detail
• Ability to analyze, interpret, and summarize moderately complex data with general oversight
• Understanding of established procedures and industry practices for drug development and PV
• Basic knowledge of related disciplines and general concepts within those areas
• Computer skills to support use of electronic systems and development of writing deliverables