Drug Safety Associate - Munich, Deutschland - OPTARES Gmbh & Co. KG

OPTARES Gmbh & Co. KG

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

[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 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

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 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