Global Pharmacovigilance Alliance Specialist - Nuernberg, Deutschland - ITM Isotope Technologies Munich SE
Beschreibung
Your Role:
- Be the primary contact and responsible for Safety Data Exchange Agreements (SDEAs) and Master Service Agreements (MSAs) between ITM and international Pharmacovigilance stakeholders, including local Pharmacovigilance partners and distributors
- Prepare, review and coordinate Safety Data Exchange Agreements and Master Service Agreements between ITM and third parties, ensuring all input from Pharmacovigilance stakeholders is implemented
- Prepare, review and coordinate the Safety Data Exchange Agreements for Investigator Sponsored Studies to ensure correct and timely exchange of safety information arising from the study
- Ensure that the relevant productrelated safety information is exchanged effectively and timely between external Pharmacovigilance stakeholders and ITMinternal departments (e.g. Sales, Clinical Operations, Regulatory Affairs)
- Maintain Pharmacovigilance Global Alliance oversight by means of tracking tools to ensure all relevant information with respect to Safety Data Exchange Agreements is up to date
- SOP Management: Support the Drug Safety & Pharmacovigilance team in the preparation and review of Global Pharmacovigilance Alliance related SOPs
What we are looking for:
- University degree with a focus on the natural sciences
- Advanced verbal, written and presentation skills
- Good organizational and coordination skills
- Solutionoriented and "handson" attitude
- Fluent written and spoken English, German knowledge preferred but not mandatory
- MS Office knowledge (Excel, Word, Powerpoint)
What we offer:
- A modern workplace and exciting opportunities in an evolving and fast growing company
- Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
- A collegial corporate culture and short communication channels
- Flexible working hours with an attractive salary package, diverse corporate benefits and home office possibilities
Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than "maybe".
Then send us your detailed CV including earliest start date and salary expectations. The position is intended for the ITM Oncologics GmbH, a company of the ITM group. Applications are accepted either in German or English language.
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