Senior Pharmacovigilance Officer

vor 4 Wochen

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
Senior Pharmacovigilance Officer / Deputy EU/UK QPPV / Deputy Graduated Plan Officer

At Merz Therapeutics, we are seeking a highly skilled and experienced Senior Pharmacovigilance Officer to join our team. As a key member of our Pharmacovigilance Group, you will play a critical role in ensuring the safety and quality of our products.

Key Responsibilities:
  • 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, contractual agreements, and work instructions.
  • Develop and maintain 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.
  • Participate in PV audits and 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.
What We Offer:
  • Individual career development in a purposeful job.
  • Hybrid work model that allows a good work-life balance.
  • Attractive location with good transport links, modern workplaces, and a company restaurant.
  • Global family business with flat hierarchies and an open, respectful corporate culture.
  • Attractive remuneration with extensive social benefits.
  • Variety of employer-subsidized benefits such as Wellpass, Germany ticket, Corporate Benefits, and JobBike.

Find out more about our benefits here.

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