The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. We are an entrepreneurial specialist delivering true benefits to patients. By sustainably investing in research and development above the industrial average, we are committing to innovation in order to treat unmet medical needs and bring value-adding products to markets. Grünenthal is a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients.
Post : Drug Safety Specialist
Responsibilities:
- Perform triage, quality check, scientific assessment and review of single case reports of any Grünenthal medicinal product and provide medical input as needed (including narrative writing, prioritization, assessment of expectedness, causality and seriousness)
- Support all steps in case processing as required
- Ensure consistency in the coding and evaluation of SAE reports
- Identify appropriate follow-up information required for case reports
- Perform trainings on single case report evaluation
- Liaise with the Global Safety Leads and Study Responsible Functions regarding case report documentation, quality and medical assessment
- Support ICSR process development projects to meet various regulatory and departmental goals
- Manage and further develop assigned processes, metrics and procedural documents linked to ICSRs
- Align with global functions involved in ICSR handling to ensure the appropriate standards are practiced consistently
Candidate Profile :
A scientific university degree in medicine or pharmacy, or in other relevant life science area.
Experience in pharmacovigilance case processing is desired but similar experience can be also considered.
Understanding of regulations and standards relevant to safety of drugs in development and post authorization.
Knowledge of clinical research would be an advantage
Good knowledge of English (both spoken and in writing)
Additional info:
Qualification: B.Pharm
Location: Germany - Aachen
Area: Drug Safety & Regulatory Affairs
Requisition Number: 23639
Apply Online : Click here
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