Senior Pharmacovigilance Officer / Deputy EU/UK QPPV / Deputy Graduated Pla

at  Merz Therapeutics

YOUR CONTRIBUTION

Join our Pharmacovigilance Group within Global Product Safety and grow with new challenges. Your scope of work with us will include the following tasks:

• As Deputy EU/UK QPPV and Deputy Graduated Plan Officer (“Stufenplanbeauftragter”), you will maintain the oversight of the timely preparation and maintenance of essential documents in the area of pharmacovigilance, such as the PV System Master File, safety reports (e.g. PSURs, RMPs), contractual agreements with license/distribution partners and service providers, work instructions etc.

Maintaining and shaping the international pharmacovigilance (PV) system for all drugs of Merz Therapeutics including Merz Entities, license/distribution partners and service providers of Merz Therapeutics focusing on maintaining information channels, responsibilities, and work processes in collaboration with the QPPV and the “Stufenplanbeauftragter”.

• Accompanying and monitoring of risk and referral procedures and coordination of the resulting measures, e.g. recalls / risk defense
• Active preparation and participation in PV audits and PV inspections and to ensure the implementation of resulting Corrective and Preventive Actions
• Creation and updating of local and global PV operating procedures and work instructions (SOPs, WIs)

• Commissioning and supervision of vigilance service providers for outsourced vigilance activities as well as preparation and updating of the corresponding contracts.

• • Creating and updating Safety Agreements for the exchange of safety-related information with Merz affiliates, as well as licensing and distribution partners worldwide

ABOUT US

Welcome to Merz Therapeutics, 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 proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.
Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.
Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.
Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal:

Join our Pharmacovigilance Group within Global Product Safety and grow with new challenges. Your scope of work with us will include the following tasks:

• As Deputy EU/UK QPPV and Deputy Graduated Plan Officer (“Stufenplanbeauftragter”), you will maintain the oversight of the timely preparation and maintenance of essential documents in the area of pharmacovigilance, such as the PV System Master File, safety reports (e.g. PSURs, RMPs), contractual agreements with license/distribution partners and service providers, work instructions etc

Maintaining and shaping the international pharmacovigilance (PV) system for all drugs of Merz Therapeutics including Merz Entities, license/distribution partners and service providers of Merz Therapeutics focusing on maintaining information channels, responsibilities, and work processes in collaboration with the QPPV and the “Stufenplanbeauftragter”.

• Accompanying and monitoring of risk and referral procedures and coordination of the resulting measures, e.g. recalls / risk defense
• Active preparation and participation in PV audits and PV inspections and to ensure the implementation of resulting Corrective and Preventive Actions
• Creation and updating of local and global PV operating procedures and work instructions (SOPs, WIs)
• Commissioning and supervision of vigilance service providers for outsourced vigilance activities as well as preparation and updating of the corresponding contracts