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.
As our new Director, Global PV Operations you will become responsible for PV Operations activities and provide strategic and operational PV/quality/safety support for Ascendis Pharma’s portfolio of products in close collaboration with cross-functional colleagues. You will join a dynamic team of PV Professionals, and 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 ability to adapt 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: 20 - 30 days a year.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.
Applications will be evaluated when received, so please apply as soon as possible.
- You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
- Laptop, iPhone, paid internet, and home office equipment.
- A thorough and structured onboarding program.
- To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.
- Soft drinks, fresh fruit, and a wide variety of snacks every day, no strings attached.
- To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. If a need is identified, we will find a way to help you grow.