Associate Director, PV Alliance Management

Are you passionate about pharmacovigilance and establishing relationships with key partners? Do you have experience in a drug safety environment with pharmacovigilance operational responsibilities and negotiating contracts with strategic partners?

If so, now is your chance to join Ascendis Pharma as our new Associate Director, PV Alliance Management.

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.

We are seeking a passionate Associate Director, PV Alliance Managementto join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in overseeing pharmacovigilance requirements for all Ascendis Pharma collaborations. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the QPPV office team consisting of 2 colleagues, and report directly to Eva Widebæk Rasmussen, Senior Director, EU QPPVwho is based in our office in Hellerup.

Your key responsibilities will be:

• Serve as the main point of contact for established Business Partners for all Pharmacovigilance activities.
• Collaborate with internal stakeholders to ensure alignment on PV responsibilities and adherence to established agreements and Ascendis SOPs.
• Responsible for establishing and maintaining Safety Data Exchange Agreements (SDEAs) and PV Agreements with Business Partners.
• Ensure exchange of safety information with partner companies in accordance with Safety Data Exchange Agreements (SDEAs) and regulatory requirements.
• Ensure compliance with commitments outlined in the global/local SDEAs as well as ensures the implementation of effective corrective and preventative action plans are in place for any quality issues.

Qualifications and Skills:
You hold a relevant academic degree – preferably a Master within a health care field and experience within drug safety and minimum 3 years of experience in Pharmacovigilance. You have solid knowledge of EMA & FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents.

Furthermore, you have:

• An independently and initiative approach. You demonstrate ownership, and accountability and displays a high level of commitment.
• Excellent communication skills, both written and verbal, with credibility and confidence.
• Excellent negotiation and networking skills and demonstrated problem solving ability.
• Strong organizational and collaborative skills. You are an effective team player who can navigate multifunctional and multidisciplinary team setting.
• An eye for detail and thrives in a dynamic, fast paced environment.

Key competencies:

• You are a strong team player, analytical, and have a can-do attitude.
• You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.
• You are experienced with negotiating and maintaining partner contracts including building trust and foster collaboration between partners during the course of an alliance.
• You have demonstrated skills within in decision-making and problem-solving, and you are able to determine if escalation is needed for contractual issues.

Travel: 10 – 15 days per year.

Office: Ascendis Pharma Headquarter, Hellerup
For more details about the position or the company, please contact Eva Widebæk Rasmussen, Senior Director, EU QPPV, [email protected] or visit out website www.ascendispharma.com

Applications will be evaluated when received, so please apply as soon as possible.

All applications must be submitted in English and are treated confidentially.

Benefits

• 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 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 find a way to help you grow.
• Soft drinks, fresh fruit and lunch every day in our canteen.
• Ascendis Pharma headquarters resides in a modern and bright office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
• To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.

Hellerup