Senior Pharmacovigilance Officer 12 Months FTC

Warsaw Poland Hybrid

At Theramex we are driven by a clear purpose by improving the lives of women around the world through innovative and accessible healthcare. As one of the fastestgrowing global specialists in Womens Health we combine the agility of a scaleup with the impact and ambition of a privateequitybacked organisation. Here your work translates into realworld outcomes - shaping portfolios influencing strategic direction and driving meaningful change for patients. Youll join a collaborative highperforming team that values expertise encourages fresh thinking and empowers people to lead with ownership. If you are motivated by purpose growth and the opportunity to make a lasting difference Theramex offers a place where your contribution truly matters.

About you

You are an experienced Pharmacovigilance professional with a strong scientific mindset and a passion for patient safety. You bring:

A 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 qualitydriven 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
A collaborative mindset with the ability to work independently in a selfdirected manner
Experience mentoring or supporting junior colleagues (highly valued)

About the role

As a Senior Pharmacovigilance Officer you will be a key member of the Global Theramex Pharmacovigilance Team based at our Warsaw headquarters and reporting to the Associate Director PV.

This role provides advanced operational and scientific oversight across safety surveillance risk management compliance and PV documentation while contributing to the continuous evolution of Theramexs Pharmacovigilance system. You will play an important role in mentoring colleagues supporting audits and inspections and ensuring the highest standards of patient safety.

Key Duties and Responsibilities

Performing signal detection and risk management activities under the guidance of PV Physicians and senior team members prioritising risks and meaningful mitigation actions
Producing accurate fitforpurpose aggregate data reviews and signal evaluation documents with clear conclusions and recommendations
Authoring and/or reviewing PV and Regulatory documents (e.g. PSURs RMPs RSI/SmPC/PIL Health Authority responses) and contributing to study protocols
Performing and overseeing case processing activities including data entry MedDRA coding reconciliations quality control and regulatory reporting
Monitoring PV compliance activities including ICSRs periodic safety reports and safety variations
Contributing to the preparation and maintenance of the Theramex Pharmacovigilance System Master File (PSMF)
Supporting the continuous enhancement of PV processes including creation and review of SOPs and Working Instructions
Mentoring and training junior Pharmacovigilance colleagues supporting capability development within the team
Delivering PV training to internal project teams and participating in projectrelated external meetings
Supporting the negotiation and execution of Pharmacovigilance Agreements
Participating in and supporting PV audits and inspections as required
Undertaking other duties reasonably aligned with the scope of this role

What does our team say about life at Theramex

Having now been with Theramex for a few months Im really enjoying my time here. Right from the outset the onboarding experience induction and orientation have been brilliant and I already feel like I am making the most of opportunities to add value to the business in meaningful ways. Theramex has a friendly and supportive vibe and is a place where I feel supported and valued.

Umut Tarakcilar Senior Treasury Analyst

Why Join Us

• A fast-paced environment with broad exposure giving you opportunities to develop professionally - even outside your core area of expertise

• A culture that supports learning celebrates success and recognizes performance

• Opportunities for driven and talented professionals to contribute to our exciting journey

Apply Now!
Ready to make a meaningful impact in Womens Health Wed love to hear from you. Apply today and shape the future with Theramex.