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Associate Director of Medical Safety Science
2 months ago
Ascendis Pharma is seeking a highly skilled Medical Safety Science Leader to join our team. As a key member of our Medical Safety Science team, you will be responsible for ensuring the safety of our products and providing leadership in the development of safety surveillance and risk management plans.
Key Responsibilities:
- Lead the development of safety surveillance and risk management plans for drug development programs
- Provide leadership in the analysis, identification, and reporting of possible trends and concerns regarding Ascendis products
- Collaborate with Medical Monitors in Clinical Development to ensure that appropriate medical review and assessment is provided for adverse event reports and non-clinical safety findings
- Ensure that all safety reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements, and company SOPs and procedures
Requirements:
- Relevant health care professional degree (Doctor, Pharmacy, MD, PhD) with 8+ years of experience within the drug safety/pharmacovigilance area in the pharmaceutical industry
- Proficient in English at a professional level, both written and spoken
- Clinical safety and PV experience
- Proficient in using drug safety databases
- Well-versed in drug safety regulations (ICH, EMA, FDA, PV regulations etc.)
- Working knowledge of MedDRA
What We Offer:
- A dynamic and fast-growing biopharmaceutical company with a strong focus on innovation and patient safety
- A collaborative and supportive work environment with opportunities for professional growth and development
- A competitive salary and benefits package
