Drug Safety Physician

R Dpartners; Warszawa; On-site; PLN 350,000 - 437,000; Full time

Job summary

R&D Partners is seeking an experienced pharmacovigilance physician to lead medical safety activities across the lifecycle of medicinal products, ensuring compliant evaluation and regulatory submissions. You will perform safety case reviews, signal detection, and benefit-risk assessments, working with regulatory, clinical, medical affairs, and quality teams to support EU/UK QPPV responsibilities.

This role requires strong clinical judgment, global PV expertise, and the ability to influence

Qualifications

• Strong English communication skills.
• In-depth knowledge of global pharmacovigilance regulations (GVP, ICH, EMA, MHRA, FDA).
• Ability to lead and develop geographically dispersed teams.

Responsibilities

• Medical evaluation of safety data and ICSR review.
• Lead or support PSURs, RMPs and safety related documents.
• Contribute to regulatory safety submissions and safety queries responses.

Job description

Could your clinical insight and pharmacovigilance expertise influence critical safety decisions and support the ongoing development of innovative healthcare solutions?

R&D Partners is working alongside a global healthcare organisation with a longstanding heritage in developing and delivering therapies that support patients with chronic and critical care needs. Following a recent corporate transformation, the company is entering an exciting phase of growth and investment, expanding its focus across innovative treatment areas while continuing to enhance patient outcomes through digital solutions and advanced healthcare services.

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.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

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.

Key Skills and Requirements

• Build strong working relationships and collaborate effectively across multiple functions and departments.
• Demonstrate a comprehensive understanding of the global pharmacovigilance landscape and regulatory environment.
• Possess exceptional analytical thinking and problem-solving capabilities.
• Bring a professional and credible approach, with strong leadership and relationship-building skills.
• Proven ability to lead, motivate, and develop teams of varying sizes, experience levels, and professional backgrounds.
• Communicate confidently and effectively with Health Authorities and Healthcare Professionals.
• Comfortable presenting pharmacovigilance matters, safety system processes, and benefit-risk evaluations to regulatory stakeholders.
• Previous experience managing and supporting geographically dispersed teams.
• Display strong cultural awareness, with a collaborative, patient, and influential communication style.
• Excellent written and verbal communication skills in English.

Salary

• €80,000 to €100,000 per annum.

For more information, please contact William Tyler.