Pharmacovigilance Manager

Pharmacovigilance Manager

ProPharma Group

United Kingdom or Croatia

The Senior Pharmacovigilance (PV) Manager, Benefit Risk is the proactive leader of a team of Managers, Scientists, PV Coordinators and Subject Matter Experts within the Benefit Risk team. The Senior PV Manager, Benefit Risk actively contributes towards the achievement of company objectives by effectively managing their team, providing expertise to clients and senior management on matters related to benefit risk activities in PV, including aggregate reports, Risk Management Plans, signal detection, and literature monitoring, and by the acquisition, proper management, and timely delivery of projects.

The Senior PV Manager, Benefit Risk (BR) is responsible and accountable for the acquisition and proper allocation of projects within the team. The Senior PV Manager is responsible for business aspects regarding the benefit risk team including client satisfaction on current assignments as well as expansion to new assignments. The Senior PV Manager liaises with other teams across the department and company to promote collaborative working environment, sharing resources, enhance company culture, and help grow the company.

The Senior PV Manager, Benefit risk can be based at different ProPharma locations and depending on the team setup, manage a local or decentralized team.

Essential Functions

• Leads across functional teams contributing to periodic safety reports per Global Pharmacovigilance and Risk Management business rules, standard operating procedures, and global regulatory requirements.
• Supports roles involved in the creation and finalization of Aggregate Safety Reports (i.e., PSURs, PADER, DSURs, PBRERs, Addendum to Clinical Overviews, Addendum to PSURs, Summary Bridging Reports, and Annual reports).
• Leads the signal management process (i.e., signal tracking, review meetings, etc.) for assigned products and evaluate safety data and signals as part of ongoing pharmacovigilance activities.
• Coordination and performance of Literature screening activities (set-up of literature screening strategies, literature databases’ activities, assessment of the results)
• Maintains project schedules and conduct regular status reviews to ensure project timeline compliance.
• Supports and contributes to onboarding, training, mentoring, and coaching of new associates.
• Creates all documents following all applicable SOPs, and conventions of the client.
• Plans, organizes, and manages daily work to meet service-level timelines and deliverables.
• Works with the Aggregate Reporting leads to escalating issues or tasks outside the normal scope of work.
• Participates in internal and external audits and inspections by clients and health authorities.
• Continuous evaluation work taking into consideration multiple priorities – eliminate unnecessary work; reallocate resources to maintain and enhance effectiveness, thereby adding value to the company and the client.
• Actively communicates and manages relationships with functional and cross-functional team members to promote understanding, ownership, and support of the project.
• Understands current industry best practices and builds in-depth knowledge of global pharmacovigilance regulations related to aggregate safety reporting.
• Provides pharmacovigilance data analysis, authoring, and quality control (QC) expertise for the preparation of a range of global regulatory aggregate safety reports, including PADER, DSUR, PSUR/PBRER, etc.
• Partners with cross-functional colleagues to gather and provide input for appropriate sections of critical safety/regulatory documents.

Necessary Skills and Abilities

• Excellent interpersonal skills, and client focused approach to work.
• Sound planning, prioritization, and organizational skills to lead a successful team.
• Able to lead and work within a team in an open and professional manner.
• Analytical and problem-solving skills.
• Excellent attention to detail and focus on quality.
• Sound understanding of ICH-GCP, FDA, EMA and other relevant Global regulations related to PV.
• Ability to delegate effectively.
• Awareness of global culture and willingness to work in a matrix environment.
• Cross cultural understanding and working across different countries.
• Ability to author, update, and train SOPs.
• Able to prepare and participate in audits and inspections

Educational Requirements

• University degree (BSc, EQF level 6) and/or higher professional training in pharmacy, medicine, veterinary medicine, chemistry, pharm chem, nursing, and life science, Med tech, or biology.

Experience Requirements

• 7+ years’ experience in Pharmacovigilance with a focus on medical writing and/or literature search and/or signal detection.
• 2+ years’ experience in leading and developing a team, including line management.
• Well-founded experience in working together with clients and meeting their needs.
• Well-founded experience in managing and working on a wide variety of projects for different clients.
• Well-founded experience in literature screening activities and/or authoring and reviewing aggregate reports and/or experiences in authoring and updating RMPs and/or well-founded knowledge of signal detection methodologies and/or exp managing CCDSs and knowledge of regulatory safety variation processes.

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