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

Requirements

You hold a Bachelor's degree in a health-related discipline with progressive pharmaceutical industry experience in Pharmacovigilance and drug safety operations; experience supporting Data Collection Programs.

• Minimum of 7 years of progressive Pharmacovigilance experience within the pharmaceutical industry.
• Demonstrated knowledge of FDA safety regulations, ICH Guidelines, GVP requirements, and applicable global pharmacovigilance regulations and guidance.
• Experience operating in cross-functional, matrixed environments with the ability to support operational execution, compliance oversight, and inspection readiness activities.
• Ability to travel domestically and internationally up to 20% as business needs require.

As a person, you have/are:

• A passion for advancing innovative therapies that address unmet medical needs for patients struggling with Rare Endocrine Diseases

• Working independently, while having a strong ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting
• Demonstrated ability to navigate uncertainty and adapt quickly to changing priorities
• Proven track record delivering results in dynamic, fast-paced settings where clarity evolves over time
• Demonstrating ownership, initiative and accountability

The estimated salary range for this position is $165k - $175k. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.

Benefits

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of Pet Insurance and Legal Insurance
• Employee Assistance Program
• Employee Discounts
• Professional Development
• Health Saving Account (HSA)
• Flexible Spending Accounts
• Various incentive compensation plans
• Accident, Critical Illness, and Hospital Indemnity Insurance
• Mental Health resources
• Paid leave benefits for new parents