Drug Safety Associate

vor 1 Woche

Munich, Deutschland OPTARES Gmbh & Co. KG Vollzeit

[6029]

Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort.

To support our team we are looking for a

**Drug Safety Associate (M/F/d)**

Your tasks
- Support the management of third-party Pharmacovigilance vendor processes and internal processes for safety activities within an ongoing phase II to phase III clinical program and a post-marketing study
- Receiving, tracking, and filing of SAEs/AEs and expedited event reports (SUSARs/ADRs) including surveillance of timely processing by third-party vendor
- Provide sponsor oversight of SAE/AE/ADRs/SUSARs processing by an outsourced vendor including the monitoring of reporting compliance
- Co-ordinate case review with InflaRx Medical Affairs personnel and ensure implementation of recommendations
- Co-ordinate on time for data preparation with third-party vendor for periodic safety assessment (DSUR, IB, DSMB, PADER)
- Contribute to vendor surveillance with regards to invoice verification and cost control
- Ensure compliance with SOPs, GCP, and relevant regulatory environment of activities and documentation
- Maintain knowledge of adverse event reporting processes and safety systems and contribute to the development, implementation, improvement, and standardization of new processes and methods

Ihre Qualifikationen
- Bachelor’s degree in Life Sciences/Pharmacy/Medical Sciences, or other equivalent experience/education
- A minimum of 6 months of relevant experience in a pharmaceutical/ biopharmaceutical organization with safety reporting (expedited/periodic) in clinical development and post-marketing studies (US and European countries)
- First-in-hand experience with safety reporting and regulatory reporting in clinical development and post-marketing environment
- Ability to work harmoniously within international cross-functional teams, engage in open, constructive and continuous dialogue with internal staff and external partners
- Goal oriented and flexibility to adapt to changing situations in a fast-paced environment
- Highly motivated, self-driven, dependable, and solution oriented
- Effective communication skills
- Fluent in written and verbal English (business level proficiency needed). Fluency in German desirable
- Should be familiar with MS Word, Excel and PowerPoint

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