Drug Safety Associate - Munich, Deutschland - OPTARES Gmbh & Co. KG
Beschreibung
[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 aDrug Safety Associate (M/F/d)
Your tasks
- Support the management of thirdparty Pharmacovigilance vendor processes and internal processes for safety activities within an ongoing phase II to phase III clinical program and a postmarketing study
- Receiving, tracking, and filing of SAEs/AEs and expedited event reports (SUSARs/ADRs) including surveillance of timely processing by thirdparty vendor
- Provide sponsor oversight of SAE/AE/ADRs/SUSARs processing by an outsourced vendor including the monitoring of reporting compliance
- Coordinate case review with InflaRx Medical Affairs personnel and ensure implementation of recommendations
- Coordinate on time for data preparation with thirdparty 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
- 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 postmarketing studies (US and European countries)
- Firstinhand experience with safety reporting and regulatory reporting in clinical development and postmarketing environment
- Ability to work harmoniously within international crossfunctional 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 fastpaced environment
- Highly motivated, selfdriven, 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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