Senior Pharmacovigilance Medical Expert

Vantive Job Posting

Role overview

The position plays a critical role in ensuring the ongoing safety profile of the company’s medicinal products throughout their lifecycle. This position is responsible for the medical evaluation of safety data, benefit risk assessments, signal detection activities, and contributions to regulatory safety submissions. The role requires strong clinical judgment, expertise in pharmacovigilance principles, and the ability to collaborate cross functionally with regulatory, clinical, medical affairs, and quality teams. This position will also provide medical support to the EU/UK QPPV.

What you'll do

• Safety Case Evaluation

• Perform medical review of individual case safety reports (ICSRs), including serious and non‑serious adverse events from clinical trials, post‑marketing, literature, and partner sources. Provide medically sound coding, causality assessment, expectedness assessment, and clinical interpretation. Ensure compliance with global regulations and internal timelines.

• Signal Detection & Risk Assessment

• Participate in routine signal detection activities, including review of statistical outputs and aggregate data. Contribute to signal validation, prioritization, assessment, and documentation. Make clinical recommendations on further analyses, risk mitigation, and regulatory actions.

• Benefit-Risk Evaluation

• Lead or support the ongoing benefit–risk evaluations of assigned products. Provide medical input to Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and safety‑related clinical documents. Collaborate with the QPPV (if applicable) and Safety Specialist to ensure accurate product safety profiles.

• Regulatory Interaction & Documentation

• Contribute to regulatory safety submissions, including responses to Health Authority safety queries, Dear Healthcare Provider letters, and safety variations. Support the creation and maintenance of core safety documents (CDS/SmPC/PIL). Participate in regulatory inspections and audits as a subject matter expert for medical safety.

• Cross‑Functional Collaboration

• Provide medical safety expertise to clinical development, medical affairs, regulatory affairs, quality, epidemiology, and commercial teams. Serve as the safety representative on cross‑functional project teams. Support development of safety‑related training materials for internal stakeholders.

• Compliance & Process Improvement

• Ensure adherence to GVP, ICH, EMA, MHRA, FDA, and other relevant global pharmacovigilance regulations. Identify opportunities for process optimization and contribute to SOP development and updates. Uphold a culture of safety, compliance, and scientific rigor.

• What you'll bring

• Ability to liaise effectively with the different functions involved, e.g., Quality Assurance, Medical Affairs, Clinical, Medical Information, Regulatory Affairs, Sales and Marketing, etc.

• Broad understanding of the global PV environment.

• Excellent analytical and problem-solving skills.

• Mature personality with excellent leadership and interpersonal skills.

• Ability to motivate, lead and develop multiple staff of various sizes and skill sets/backgrounds.

• To be effective in communication with the Health Authorities and Health Care Professionals

• Comfort and confidence presenting pharmacovigilance system related aspects and benefit risk particularly to regulators.

• Leadership experience in managing people at a geographic distance.

• Cultural sensitivity, patient but persuasive.

• Excellent oral and written communication in English.

• We offer

• The probation period of 3 months and then for an indefinite period; Possibilities for development on a personal and professional level in one of the leading global MedTech companies; Package of benefits including Private medical care (Lux Med), Life Insurance, and Multisport card; Holiday Bonus, Annual Bonus, Newborn baby Bonus; Co-financing for corrective glasses and lenses; Benefit platform (300 PLN monthly); PPE program with very attractive conditions available for each employee after 3 months; Fully covered language courses (English or other languages according to business needs); Co-financing of holidays and an additional 2 days off from work annually; Additional extra day for a birthday! Recommend a friend - Referral Bonus; Hybrid work model; Great Warsaw office location - Powiśle!

• Compliance & Accommodations

• Reasonable Accommodation

• Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

• Recruitment Fraud Notice

• Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.