Senior Pharmacovigilance Manager, Benefit Risk

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

We're looking for an experienced and proactive Senior Pharmacovigilance Manager to lead one of the Benefit-Risk teams. In this key leadership position, you will manage a team of Scientists, Coordinators and Subject Matter Experts, drive high-quality delivery of pharmacovigilance projects, maintain excellent client relationships, and actively contribute to business growth.

Key responsibilities

• Lead and develop a high-performing signal detection team (line management, mentoring, onboarding, training & coaching)
• Coordinate signal detection, tracking, review meetings, and evaluation of safety data
• Support the delivery of aggregate safety reports (PSURs/PBRERs, DSURs, PADERs, Addendum reports, Annual Reports, etc.)
• Ensure projects are delivered on time and to the highest quality standards (timelines, SOPs, client conventions)
• Contribute to benefit-risk evaluation, Risk Management Plans (RMPs) and regulatory safety documents
• Build and maintain strong relationships with clients and cross-functional teams
• Participate in audits and regulatory inspections
• Support business development through client satisfaction and the identification of new opportunities
• Stay up-to-date with global pharmacovigilance regulations and industry best practices

Experience

• 7+ years of hands-on pharmacovigilance experience, with a strong focus on signal detection
• Strong management background in team leadership and/or projects.
• Proven track record of working directly with clients and successfully managing multiple client projects
• Solid experience in signal evaluation and medical writing.
• Good working knowledge of global PV regulations (ICH-GCP, EMA, FDA and other major authorities)

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***