Senior Medical Safety Manager

NES Fircroft; Warszawa; Hybrid; PLN 180,000 - 280,000; Full time

Benefits offered by this job

Private medical care

Life insurance

Multisport card

Annual bonus

Language courses

Job summary

NES Fircroft is seeking an experienced medical professional to join the Patient Safety function. The role focuses on overseeing medical aspects of product safety, evaluating safety data, and ensuring timely risk assessment across the lifecycle.

You will work with the EU/UK QPPV and collaborate with Regulatory Affairs, Clinical Development, Medical Affairs, and Quality to support safety strategies and regulatory submissions. Hybrid work in Warsaw is available.

Qualifications

• Medical degree with pharmacovigilance experience.
• Strong understanding of global pharmacovigilance principles and safety reporting.
• Experience in medical review of safety cases and risk evaluation.

Responsibilities

• Review and assess adverse event reports from clinical trials and post-marketing activities.
• Evaluate causality, expectedness, and medical coding to ensure accurate safety assessments.
• Contribute to safety strategy, risk minimization, and regulatory submissions.
• Provide medical safety input for PSURs, RMFs, and safety communications.

Skills

Pharmacovigilance expertise

Medical safety assessment

Regulatory knowledge

Cross-functional collaboration

English proficiency

Education

Medical degree

Job description

We are looking for an experienced medical professional to join the Patient Safety function of an international healthcare organization. The successful candidate will play a key role in overseeing the medical aspects of product safety, supporting the continuous evaluation of safety data and ensuring that potential risks are appropriately assessed and managed throughout the product lifecycle.

The role combines medical expertise, pharmacovigilance knowledge, and cross-functional collaboration. It involves contributing to safety strategies, evaluating emerging safety concerns, supporting regulatory activities, and working closely with the EU/UK Qualified Person Responsible for Pharmacovigilance (QPPV).

Key Responsibilities

• Review and assess adverse event reports originating from clinical trials, post-marketing activities, scientific literature, and external partners.
• Evaluate the clinical relevance of reported events, including causality, expectedness, and medical coding.
• Ensure that safety assessments are accurate, consistent, and completed within applicable timelines.

Safety Surveillance and Risk Management

• Contribute to the ongoing monitoring of product safety data and identification of potential safety signals.
• Evaluate emerging safety concerns and support decisions regarding further investigation and appropriate risk minimization measures.
• Participate in the preparation and review of benefit–risk assessments for assigned products.

Safety Documentation and Regulatory Support

• Provide medical input into periodic safety reports, risk management documentation, and other pharmacovigilance-related materials.
• Support the preparation of regulatory submissions and responses to questions raised by health authorities.
• Contribute to the maintenance of product safety information, including prescribing information and patient leaflets.
• Participate in audits and inspections, providing medical safety expertise when required.

Cross-Functional Collaboration

• Work closely with teams across Regulatory Affairs, Clinical Development, Medical Affairs, Quality, Epidemiology, and other relevant functions.
• Provide medical safety guidance to project teams and contribute to decisions affecting product safety.
• Support the development of internal training materials and promote awareness of pharmacovigilance requirements.

Compliance and Continuous Improvement

• Ensure that safety activities are conducted in accordance with applicable international pharmacovigilance standards and regulations.
• Contribute to the development and improvement of internal procedures, processes, and working practices.
• Support a strong culture of patient safety, regulatory compliance, and scientific integrity.

Candidate Profile

• Medical degree with relevant experience in pharmacovigilance, drug safety, or medical safety assessment.
• Strong understanding of global pharmacovigilance principles, regulatory requirements, and safety reporting processes.
• Experience in medical review of safety cases, signal management, and benefit–risk evaluation.
• Familiarity with safety documentation, including PSURs, RMPs, and product safety information.
• Ability to collaborate effectively with cross-functional teams and communicate complex medical information clearly.
• Strong analytical, organizational, and problem-solving skills.
• Experience in leading, mentoring, or developing team members, including colleagues based in different locations.
• Confidence in communicating with health authorities and healthcare professionals.
• Excellent written and spoken English.

What We Offer

• Permanent employment following a three-month probationary period.
• Hybrid working model in Warsaw.
• Private medical care, life insurance, and a Multisport card.
• Annual bonus and additional financial benefits.
• Monthly benefits platform allowance.
• Employee pension program with attractive conditions.
• Fully funded language courses.
• Holiday subsidies and two additional days off annually.
• An extra day off for your birthday.
• Employee referral bonus.
• Modern office in a central Warsaw location.
• Opportunities for professional development within an international healthcare organization.