Associate Director, Global PV Operations
Join the Global PV Operations team in a leading and fast-growing biotech company
Ascendis Pharma is currently expanding its PV operations team.
You will become responsible for PV Operations activities and also serve as the Deputy QPPV for Ascendis Pharma. Additionally, you will manage the QPPV Office and maintain an overview of the safety profiles of the company's medicinal products and any emerging safety concerns. You will join a dynamic team of PV professionals, and you will report directly to the Head of Global PV Operations.
Main areas of responsibility:
- Support Study Management Teams (SMTs) as an active member representing PV Operations team.
- Oversees the PV vendors/service providersas applicable including vendors for Patient Support Programs and Market Research Programs.
- Perform job duties typically assigned to a Deputy QPPV to support the QPPV in maintaining the Pharmacovigilance (PV) systems in line with the requirements for human pharmaceutical products
Criteria of success in the role will be to:
- Work effectively, independently, and collaboratively
- Ability to have couple of hours of overlap of work hours with colleagues based in Palo Alto, California.
- Strong organizational skills, detail oriented and adapts in a dynamic, fast paced environment
- Demonstrates ownership, initiative, and accountability
- Ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting
- Excellent communication skills, both written and verbal, with credibility and confidence
- Sound strategic evaluation, analysis, and decision-making skills as demonstrated in effective strategy formulation, tactics, and action plans to achieve results
You hold a relevant academic degree – preferably a Bachelor’s degree in a health care field with relevant pharmaceutical industry experience in drug safety. You have several years of documented experience within Pharmacovigilance from the pharmaceutical industry. Furthermore, expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations is required.
You are proficient in English at a professional level, both written and spoken, and you master MS Office.
You are a highly motivated individual who enjoys being challenged and working in collaborative environments.
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.
Travelling: 25-35 days per year.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbour, the canals, and the sea.
For more details about the company, please visit our website www.ascendispharma.com
All applications must be submitted in English and are treated confidentially.
Applications will be evaluated when received, so please apply as soon as possible.