Pharmacovigilance Vendor Management Lead - Job ID: PVL

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.

The PV Vendor Management Lead reports directly to the Head of Global PV Operations.  Under the direction of the Head of Global PV Operations, is responsible for overseeing Pharmacovigilance requirements for assigned vendors.

Key Responsibilities

• Lead & guide the development and execution of Pharmacovigilance strategy and tactics in alignment with key stakeholders for assigned Market Research and Patient Support Programs (MAPs) and GVP Service Providers.
• Serve as the main point of contact for established vendors for all Pharmacovigilance activities.
• Participate in due diligence and selection of future GVP Service providers as needed.
• Liaise with business/functional units to influence the design of Market Research and Patient Support Programs (MAPs) and GVP Service Provider processes ensuring adequate collection of safety data and their timely reporting to the safety unit.
• Responsible for establishing and maintaining Key Performance Indicators (KPI) and/or Quality Agreements as applicable.
• Monitors performance (metrics, other reports) of the Vendor and the quality output of the ICSRs; provides appropriate feedback and training.
• Acts as single point of contact for all Service Provider (SP) communications.
• Act as Pharmacovigilance subject matter expert for MAP and GVP SP processes in the event of audit or regulatory inspections.
• Identify potential risks and/or gaps associated with GVP and MAP SPs. Develop and execute risk mitigation strategies.
• Escalates issues and risks as appropriate to vendor owner, SP PV Oversight Manager and/or SP PV Oversight Head. Accountable for PV compliance for GVP or MAP SPs.

• Oversees safety data reconciliation activities and ensures safety responsibilities are completed within the required timelines.
• Monitoring of reporting and quality compliance through case oversight and quality metrics report review; ensures the implementation of effective corrective and preventative action plans are in place for any quality issues.

• Maintain understanding of responsibilities for safety reporting requirements for US, EU and other international territories, as required.
• Ensure compliance with global safety requirements and inspection readiness, ensuring non-compliance events are investigated, remediated, and prevented.

• Participate in due diligence and selection of future SPs as needed.
• Collaborate with internal stakeholders to ensure alignment on PV responsibilities and adherence to established agreements and Ascendis SOPs.
• Monitor industry best practices, changes in global safety regulations and guidelines for marketed and investigational products and recommends changes and upgrades to existing departmental policies, SOPs, and systems as appropriate.
• Additional activities may include but is not limited to:

• Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits.
• Work collaboratively with Global PV Operations, Medical Safety Science team and QPPV office for assigned activities.
• Participate in relevant crisis management activities within the scope of Ascendis PV group.
  

Competencies Identified for success:

• Works effectively, independently, and collaboratively.
• Strong project management and 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 and influencing 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.
• Displays a high level of commitment.

• Bachelor’s degree in a health care field with relevant pharmaceutical industry experience in drug safety.
• Candidates with advanced scientific degrees and extensive drug safety experience is highly desired.
• Minimum of 10 years recent experience in Pharmacovigilance and Vendor Management.
• Expert knowledge of EMA & FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
• Ability to travel up to 20% of the time domestically and internationally.

A note to recruiters:

We do not allow external search party solicitation.  Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.  If this occurs your ownership of these candidates will not be acknowledged.

• 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