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Director of Medical Safety Science
2 months ago
About TSP (A Syneos Health Company)
TSP is a leading biopharmaceutical company that offers a dynamic and fast-paced work environment. As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.
Job Summary
We are seeking a highly experienced and skilled Director of Medical Safety Science to join our team. As a key member of our Medical Safety Science department, you will be responsible for ensuring corporate compliance with all applicable laws and regulations and for signal detection, evaluation, and risk management.
Key Responsibilities
- Leadership Role
- Adopt a leadership role for assigned products (development and post-marketing) and work closely with the Head of Global Medical Safety Science and Head of Global PV Operations in activities for monitoring patient safety, e.g., adverse event reports for potential safety-related issues and provide recommendations when potential issues are identified.
- Safety Reporting
- Ensure that all safety reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements, and company SOPs and procedures.
- Collaboration
- Liaise 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.
- Safety Signal Identification
- Responsible for the analysis, identification, and reporting of possible trends and concerns regarding Ascendis products and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports, and review of relevant literature for safety information pertinent to product safety.
- Regulatory Compliance
- Provide leadership to the development of safety surveillance and risk management plans for drug development programs and safety input to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report, etc.).
- Document Review
- Assist in the preparation and review of safety sections of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions, and other relevant documents to ensure the safety profile of the products is reflected accurately.
- Regulatory Response
- Lead responses to ad-hoc safety queries from Regulatory Authorities in a timely manner and ensure the stakeholders are involved in crafting and tracking the responses.
Requirements
We are looking for a highly experienced and skilled professional with:
- A relevant health care professional degree (Doctor, Pharmacy, MD, PhD) with experience within the drug safety/pharmacovigilance area in the pharmaceutical industry.
- Proficiency in English at a professional level, both written and spoken.
- Clinical safety and PV experience.
- Proficiency in using drug safety databases.
- Well-versed in drug safety regulations (ICH, EMA, FDA, PV regulations, etc.).
- Working knowledge of MedDRA.
About You
We are looking for a team player with a collaborative mindset, excellent communication skills, and good time management skills. Ideally, you should be proficient in the use of Microsoft Office products and have a working knowledge of MedDRA.
Location
Ideally based in Denmark or Sweden.
