Associate Director of Medical Safety Science
1 month ago
Ascendis Pharma is seeking a highly skilled Associate Director of Medical Safety Science to join our team. As a key member of our Medical Safety Science team, you will be responsible for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements.
Key Responsibilities:
- Lead the development and implementation of safety surveillance and risk management plans for drug development programs.
- Provide leadership to 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.
- Develop and maintain relationships with Regulatory Authorities to ensure timely and effective responses to ad-hoc safety queries.
- 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-paced work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
- The chance to work with a talented and passionate team.
Travel: 15-25 years a year.
Location: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.
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