Senior Pharmacovigilance Officer
vor 1 Woche
Role Overview
As a Senior Pharmacovigilance Officer at Merz Therapeutics, you will play a crucial role in maintaining the oversight of the timely preparation and maintenance of essential documents in the area of pharmacovigilance. This includes the PV System Master File, safety reports, contractual agreements, and work instructions.
Key Responsibilities
- Maintain and shape the international pharmacovigilance system for all drugs of Merz Therapeutics, including Merz Entities, license/distribution partners, and service providers.
- Accompany and monitor risk and referral procedures, and coordinate the resulting measures, such as recalls and risk defense.
- Prepare and participate in PV audits and PV inspections, and ensure the implementation of resulting Corrective and Preventive Actions.
- Create and update local and global PV operating procedures and work instructions.
- Commission and supervise vigilance service providers for outsourced vigilance activities, and prepare and update the corresponding contracts.
- Create and update Safety Agreements for the exchange of safety-related information with Merz affiliates, as well as licensing and distribution partners worldwide.
Requirements
- Licensed pharmacist or comparable scientific education.
- Experience as Deputy Commissioner of the Graduated Plan and/or Deputy EU/UK QPPV.
- Several years of experience in pharmacovigilance and understanding of PV legislation in Germany, Europe, and the UK.
- Knowledge in the field of Regulatory Affairs for medicinal products.
- Regular further training with regard to current developments in the field of drug safety/PV and Good Pharmacovigilance Practice.
- Fluent in written and spoken English and strong communication skills.
- Strong analytical skills and ability to work scientifically.
- Very careful, conscientious way of working and ability to work in a team.
- High level of resilience and self-organization.
- Confident handling of Microsoft Office package, if necessary knowledge in handling drug safety databases.
About Us
Merz Therapeutics is a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases, and other health conditions regain their quality of life. We are a family-owned and value-driven company dedicated to serving the needs of our patients for 110 years and are now a global innovation leader with products in more than 90 countries.
We are committed to using our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings. Our goal is to use our products to make a positive impact on people's lives.
Join us in our mission to achieve better outcomes for more patients.
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