Overview
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
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.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
Are you passionate about patient safety and ready to be part of a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking a Senior Manager with a passion for safety excellence and data compliance to support our growing portfolio.
The Role
The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor Management Team within the Global Patient Safety (GPS) organization. Under the direction of the Head, PV Vendor Management Team is responsible for all Vendor Management related activities.
Key Responsibilities
Pharmacovigilance related responsibilities during the initiation, conduct and closure of Organized Data Collection programs for marketed products. These activities include, but are not limited to:
- Liaise with functional units to identify Market Research Programs, Patient Support programs and other Organized Data Collection programs
- Ensure all programs are identified and tracked appropriately throughout the program lifecycle (initiation, conduct and closure)
- Provide strategic input on the conduct of program to ensure compliance with PV requirements (e.g. add applicable PV language to vendor contracts, establish AE exchange method & timelines, and more)
- Ensuring SP/vendor oversight under the guidance of Head of PV Vendor Management
- Accountable for maintaining oversight over Source data quality check [SDQC] activities and/ or Case Transmission Verification (CTV) activities and ensure tracking and timely completion
- Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / vendors as required
- Monitoring SPs/vendors to identify areas of risk and develop strategy and action plans to ensure compliance
- Overseeing and supporting implementation of CAPAs as necessary
Work Closely with Ascendis GVP Compliance team and Commercial organization as required to ensure oversight of SPs/vendors.
Oversee the vendors/service providers to ensure that they fulfill their accountabilities and responsibilities, which in includes, but is not limited to:
- Responsible for assigned PV activities/projects and working collaboratively with other teams within Ascendis
- Ensures that Adverse Events from Organized Data Collection programs involving Ascendis products be collected, reported, and handled in accordance with global/local regulatory requirements and company policies. Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
- Functions as a PV advisor to Medical Affairs, Commercial Organizations and other relevant stakeholders as applicable
- Ensures processes are adhered to that support on time and appropriate ICSR submissions
- Provides pharmacovigilance expertise to Ascendis or Vendor staff when needed
Additional activities may include but are not limited to:
- Maintains strong relationships and communication with key stakeholders, including Commercial leadership, and GPS leadership to address queries, share metrics, and discuss new program-related processes
- Through coordination with Ascendis GVP Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits
- Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF)
- Work collaboratively with ICSR Management, Clinical Trial, EU QPPVand Medical Safety Science team for assigned activities
- Implementation Coordination activities and associated tracking as necessary
- Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head of PV Vendor Management (example: Local PV agreements, CRMs, NPP’s, Digital Media etc.)
- Participate in relevant crisis management activities within the scope of Ascendis PV group
