Director of Medical Safety Science

at  TSP A Syneos Health Company

Description
Our client is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark that offers you room to grow and the freedom to take responsibility while making a difference for patients every day. As a member of their global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.
As the new Director of Medical Safety Science, you will under the direction of Head of Global Medical Safety Science, be responsible for the company’s Drug Safety PV related activities for the assigned products.
You will join a team of colleagues in Denmark and US, reporting directly to Head of Medical Safety Science.

YOUR PROFESSIONAL QUALIFICATIONS

You hold a relevant health care professional degree (Doctor, Pharmacy, MD, PhD) with experience within the drug safety/pharmacovigilance area in the pharmaceutical industry. You are proficient in English at a professional level, both written and spoken.

Furthermore, you have:

• Clinical safety and PV experience
• Proficient in suing drug safety database
• Well versed in drug safety regulations (ICH, EMA, FDA, PV regulations etc)
• Working knowledge of MedDRA

• For ensuring corporate compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management.
• Adopting a leadership role for assigned products (development and post marketing) and work closely with 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.
• Ensuring that all safety reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.
• Liaising 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.
• 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.
• Providing 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.).
• Assisting in the preparation and review of safety section(s) 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 are reflected accurately.
• Leading 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.