Senior Pharmacovigilance Officer

1w1 week ago

Theramex

Warsaw, PL · Contract · PLN 200,000 – PLN 280,000

About this role

At Theramex we are driven by improving the lives of women around the world through innovative and accessible healthcare. As one of the fastest-growing global specialists in Women’s Health, we combine the agility of a scale-up with the impact of a private-equity-backed organisation. As Senior Pharmacovigilance Officer, provide advanced operational and scientific oversight across safety surveillance, risk management, compliance, and PV documentation.

Perform signal detection and risk management activities, prioritising risks and mitigation actions under PV Physicians. Produce accurate, fit-for-purpose aggregate data reviews and signal evaluation documents with clear conclusions. Author and review PV documents like PSURs, RMPs, RSI/SmPC/PIL, and Health Authority responses.

Based in Warsaw hybrid, join the Global Theramex Pharmacovigilance Team reporting to Associate Director PV. Play key role in mentoring colleagues, supporting audits and inspections, ensuring highest standards of patient safety. Work in collaborative, high-performing team valuing expertise and fresh thinking.

Contribute to continuous evolution of Theramex’s Pharmacovigilance system, enhancing processes, SOPs, and PSMF maintenance. Motivated by purpose, growth, and opportunity to make lasting difference. Your work translates into real-world outcomes, shaping portfolios and influencing strategic direction.

Requirements

BSc or MSc in Life Sciences
Extensive experience in Drug Safety / Pharmacovigilance with strong knowledge of global PV regulations and GVP modules
Proven experience in authoring and reviewing safety documents such as PSURs, RMPs, and responses to Health Authorities
Strong understanding of signal detection, risk management, and aggregate safety data review
Confidence using medical terminology, safety databases, and performing quality-driven case processing activities
Excellent written and verbal communication skills in English
High attention to detail, strong organisational ability, and excellent narrative writing skills
Demonstrated ability to multitask, manage projects, and work effectively in a changing environment

Responsibilities

Perform signal detection and risk management activities under guidance of PV Physicians and senior team members
Produce accurate, fit-for-purpose aggregate data reviews and signal evaluation documents with clear conclusions and recommendations
Author and/or review PV and Regulatory documents such as PSURs, RMPs, RSI/SmPC/PIL, Health Authority responses
Perform and oversee case processing activities including data entry, MedDRA coding, reconciliations, quality control, regulatory reporting
Monitor PV compliance activities including ICSRs, periodic safety reports, and safety variations
Contribute to preparation and maintenance of Theramex Pharmacovigilance System Master File (PSMF)
Support continuous enhancement of PV processes including creation and review of SOPs and Working Instructions
Mentor colleagues and support audits and inspections