Pharmacovigilance Manager
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Job Location:
Monthly Salary:
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Location: Warsaw / Hybrid
About You
You hold a BSc or MSc in Life Sciences.
You bring over 5 years experience in Drug Safety/Pharmacovigilance with strong understanding of global PV regulations and GVP modules.
You have a proven track record in planning and authoring safety documents (e.g. PSURs RMPs) with excellent medical writing skills and impeccable attention to detail.
You have experience leading strategy formulation managing multiple projects and navigating change.
Youre confident with medical terminology skilled in communication highly organised and comfortable working in rapidly evolving environments.
You can work independently and as part of a team prioritising effectively while managing diverse tasks.
You are fully proficient in English (spoken and written).
About the Role
As a Pharmacovigilance Manager within our Global Theramex Pharmacovigilance Team based in Warsaw HQ you will provide strategic and operational pharmacovigilance expertise. This is a hands-on role with responsibility for safety surveillance risk management compliance and authoring of key PV documentsespecially aggregate safety reports.
Your responsibilities will include:
Leading global aggregate safety reporting (planning authoring compliance).
Performing signal detection and risk management activities providing clear recommendations and prioritising mitigation actions that add value for patients.
Producing highquality aggregated data reviews and signal evaluations with clear conclusions and actions.
Authoring and/or reviewing PV and regulatory documents (e.g. PSURs RMPs RSI HA responses) and contributing to study protocols.
Monitoring PV compliance (including ICSRs aggregate reports and safety variations).
Contributing to the preparation and maintenance of the Pharmacovigilance System Master File (PSMF).
Enhancing PV processes by reviewing and creating SOPs Work Instructions and procedural documents.
Supporting case processing activities (data entry coding reconciliations QC reporting).
Mentoring and training junior colleagues and delivering PV training to project teams or external partners.
Participating in the negotiation and execution of PV agreements.
Supporting and participating in PV audits and inspections as required.
Performing any other responsibilities reasonably aligned with 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
Be part of a dynamic team at Theramex where youll have the opportunity to make a significant impact on womens health. We offer:
A fast-paced environment with broad exposure where you can develop professionally even outside your area of expertise.
Support for your continued growth learning and development with celebration of success and recognition of performance.
Opportunities for driven and talented professionals who want to be part of our exciting journey.
Apply Now!
If youre passionate about making a difference and meet the qualifications wed love to hear from you. Apply today to join our team at Theramex.
Key Skills
- Restaurant Experience
- Customer Service
- Employee Evaluation
- Management Experience
- Math
- Employment & Labor Law
- Sanitation
- Leadership Experience
- P&L Management
- Mentoring
- Supervising Experience
- Restaurant Management
About Company
We are Theramex, a global specialty pharmaceutical company solely committed to supporting the health needs of women through every stage of life.Wework closely with our partners, healthcare professionals, and patients to help women find the solution that may be right for them at the ti ... View more
