Pharmacovigilance (PV) Officer
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Job Location:
Monthly Salary:
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
Location: Warsaw / Hybrid
About You
You hold a Bachelors or Masters degree in Life Sciences.
You bring a minimum of 2 years experience in Case Processing and/or Drug Safety/Pharmacovigilance with solid knowledge of global PV regulations.
You are detailoriented organised confident with medical terminology and able to communicate effectively in English (written and spoken).
Youre experienced in using safety databases and familiar with EudraVigilance (advantage).
You can multitask manage projects work independently as well as collaboratively and are eligible to work in Poland.
About the Role
As a Pharmacovigilance (PV) Officer you will play a key role within our Global Theramex Pharmacovigilance Team based in our Warsaw HQ. This position provides hands-on experience across multiple areas of Pharmacovigilance contributing directly to patient safety and product quality.
Your responsibilities will include:
Performing full and accurate case processing including triage MedDRA coding seriousness assessment narrative writing and data entry into the global safety database in line with SOPs and regulatory requirements.
Managing ICSR follow-ups and submitting ICSRs to various Health Authorities.
Conducting AE/SAE reconciliation.
Performing global literature reviews using tools such as Embase and MLM service.
Handling EudraVigilance activities including downloading and submitting ICSRs.
Supporting the maintenance and use of the global safety database.
Contributing to signal detection and risk management activities under guidance from senior team members and PV Physicians.
Supporting development of PV and Regulatory documents (e.g. PSURs RMP RSI HA responses) as required.
Contributing to the preparation of the Theramex PSMF.
Participating in PV audits and inspections.
Contributing to enhancements of SOPs working practices and PV processes.
Processing PV-related deviations and CAPAs.
Performing other tasks reasonably aligned with the scope of this role.
What does our team say about life at Theramex
Theramex is committed to womens health and is making a huge positive impact to womens lives. I feel this daily in my interactions in the field. It fuels my passion to contribute as I can see feel and hear the impact in my area. How does it make me feel Empowered and proud!
Claire Holmes Womens Health Account Manager
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
- CCTV
- Federal Agencies
- Customer Service
- Clearance
- Facility
- Suspicious Activity
- Property Damage
- Public Safety
- Daily Operations
- Professional Development
- Access Control
- Communication
- General Public
- Procedures
- Powerpoint
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
