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Regulatory Affairs Specialist Role
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Regulatory Affairs Case Manager
vor 1 Woche
About Us
At Skilled - Recruitment Solutions GmbH, we are committed to providing exceptional recruitment services to the pharmaceutical industry. Our team of experts has extensive knowledge and experience in pharmacovigilance and drug safety, and we are dedicated to helping our clients find the best talent in the market.
We are seeking a highly skilled Drug Safety Specialist to join our team. As a Drug Safety Specialist, you will be responsible for ensuring the safe and effective use of pharmaceutical products through the identification and management of potential risks.
Responsibilities
- Risk Assessment: Conduct thorough risk assessments to identify potential hazards associated with pharmaceutical products.
- Case Management: End-to-end processing of adverse event case reports, including case triage, data entry, AE coding, narrative writing, quality control, and timely submission of expedited AE reports to health authorities.
- Cross-Functional Collaboration: Work closely with cross-functional teams, including regulatory affairs, marketing, and sales, to ensure effective risk management and regulatory compliance.
