Product Safety Specialist

vor 3 Wochen

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit


Product Safety Specialist (m/w/d) Global Case Management
  • Full-time
  • Frankfurt am Main, Germany
  • With professional experience

YOUR CHALLENGE

Join our Case Management Team in the field of Global Product Safety and embrace exciting challenges while ensuring our compliance in processing adverse event reports related to our pharmaceuticals.

Your responsibilities will include, but are not limited to:

  • Collecting (Triage, Duplicate check) incoming reports of adverse events from spontaneous reporting or clinical trials

  • Coding medical terminology according to MedDRA in the electronic database during data entry

  • Monitoring and coordinating the entire workflow of case processing through our service provider

  • Timely reporting of adverse events to the relevant authorities and forwarding to internal and external recipients

  • Coordinating and/or creating queries to obtain necessary additional information, including documentation and follow-up
  • Conducting and documenting the reconciliation of received and exchanged adverse event reports with internal and external sources, as well as in clinical studies (SAE-Reconciliation)

  • Creating and maintaining pharmacovigilance-related standard operating procedures in the area of ICSR Management

  • Preparing, participating in, and following up on regulatory inspections and internal audits (GxP Compliance) concerning case management

YOUR PROFILE

  • Completed training as a Medical Documentarian or a comparable pharmaceutical or medical qualification (e.g., pharmaceutical-technical assistant or medical-technical specialist) or healthcare professional
  • Several years of professional experience in the field of drug safety

  • Experience in configuring and validating safety databases and vendor management

  • Solid knowledge of medical terminology with experience in coding according to MedDRA

  • Proficient in German and good English skills, both written and spoken, along with a proficient use of MS Office applications

  • Ideally, experience with an electronic safety database

  • Excellent self-organization, reliability, and meticulous work ethic

  • Team-oriented with strong communication skills

YOUR BENEFITS

  • Individual career development in a meaningful profession: You enhance the quality of life for our patients
  • Hybrid working model that allows for a balanced work-life integration
  • Attractive location with good transport links, modern equipped workplaces, and subsidized company restaurants
  • International family-owned company with flat hierarchies and an open, appreciative corporate culture
  • Attractive compensation with extensive social benefits
  • A variety of employer-subsidized benefits such as Wellpass, Germany ticket, Corporate Benefits, and JobBike

Learn more about our offerings.

ABOUT US

Welcome to Merz Therapeutics, a leading pharmaceutical company dedicated to helping individuals with movement disorders, neurological diseases, liver conditions, and other health issues regain their quality of life.

We take pride in being a family-run and values-driven company committed to the needs of our patients for over 110 years, now represented in over 90 countries with our products as a global innovation leader.

Our goal is to improve treatment outcomes for patients worldwide and alleviate the suffering of affected individuals and their families.

Our commitment to relentless research and development helps identify unmet patient needs and offer tailored treatment methods.

Become part of our international and motivated Merz Therapeutics family and help us achieve our goal: "BETTER OUTCOMES FOR MORE PATIENTS"

For more information, please visit our website.

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