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Drug Safety Associate (m/f/d) (DE)
[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 Your qualifications ·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 Für weitere Fragen steht Ihnen gerne Frau Osmarina Pereira unter der Rufnummer +49 441 21879-31 oder via E-Mail an osmarina.pereira@optares.de zur Verfügung.
- 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
Your qualifications
- 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
Osmarina Pereira