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Physician, Pharmacist - Pharmacovigilance (m / f / d)

Physician, Pharmacist - Pharmacovigilance (m / f / d)

ITM Isotope Technologies Munich SEGarching bei München, Bayern, Germany
Vor einem Tag
Stellenbeschreibung

About ITM

ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).

We would like to fill the following permanent vacancy in a remote-based or hybrid working model in Garching as soon as possible.

Deputy Graduated Plan Officer (GPO) / Stellvertretender Stufenplanbeauftragter (f / m / d)

Your role

  • Fulfil the role of the GPO during the absence of the appointed GPO, according to the relevant legislation and guidelines
  • Set up and manage a pharmacovigilance system (§ 63a of AMG)
  • Collect and evaluate reports of drug risks and coordinate the necessary measures and responsibility for fulfilling notification obligations insofar as they relate to drug risks (§ 63a of AMG and § 19 of AMWHV)
  • Inform the qualified person of the necessary measures (§ 19 of AMWHV & § 14 of the Medicines Act)
  • Inform the competent authority immediately of any defect that could lead to a recall or an unusual restriction on distribution and shall also state the countries to which the medicinal product was shipped or exported
  • Inform the authority immediately of any suspicion of counterfeit medicinal products or active ingredients; in the case of medicinal products intended for human use, the marketing authorisation holder shall also be informed

Your profile

  • Completed degree of a Medical Doctor, Pharmacist or equivalent with extensive work experience in a similar role in pharmacovigilance
  • Experience working in a cross-functional team within a matrix environment
  • Advanced knowledge of regulations governing Pharmacovigilance in the pharmaceutical industry and R&D processes in Europe and globally
  • Excellent analytical, problem-solving, strategic planning, and interpersonal skills
  • Open to changes, suggestions and innovations; drive for continuous improvement
  • Fluent in English and German

    • Our offer

  • Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom
  • An open working atmosphere in an international corporate culture with short communication channels
  • Comprehensive onboarding programme
  • Flexible working hours with home office options
  • Attractive special payments
  • Just a good salary? Not with us! We also offer you :

    • Employee participation programme

  • Job bike or subsidised job ticket
  • Above-average contribution to the company pension scheme
  • Individually tailored further training programme (including German and English courses)
  • Health promotion programmes (e.g. EGYM Wellpass, subsidy for local fitness studio, sponsorship of sporting events, various lifestyle coaching sessions)