Associate Director, PV Vendor Management Team - Job ID: 1697
Associate Director, PV Vendor Management Team - Job ID: 1697
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Job Description
Ascendis Pharma is a dynamic fast-growing global biopharmaceutical company with locations in Denmark Europe and the United States. Today were 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 Associate Director 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 for assigned vendors. This individual has accountability for the assigned Vendor Management activities in Ascendis.
Key Responsibilities
Pharmacovigilance related responsibilities over GVP Patient Support Programs (PSPs) and other Service Providers (SPs) vendors. These activities include but is not limited to:
- Liaise with functional units to identify Market Research and Patient Support programs (MAPs)
- Ensure all MRP and PSP programs are identified and tracked appropriately
- Provide strategic input on the conduct of MAPs to ensure compliance with PV requirements
- Ensuring SP/vendor oversight under the guidance of Head of PV Vendor Management by contributing to the Vendor Quality Agreements
- 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 GVP and PSP SPs 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 GCP/PV Compliance team and Commercial organization as required to ensure oversight of GVP and PSP SPs
Oversee the GVP vendors/service providers to ensure that they fulfill their accountabilities and responsibilities which 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 Market Research and Patient Support programs (MAPs) involving Ascendis products be collected reported and handled in accordance with global/local regulatory requirements and company policies
- Responsible for operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable
- 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:
- Participate in the bid defense process for Vendor selection as applicable.
- Maintains strong relationships and communication with key stakeholders including Commercial leadership and GPS leadership to address MAP queries share metrics and discuss new MAP-related processes.
- 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
- Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF)
- Work collaboratively with ICSR Management Clinical Trial QPPV office and Medical Safety Science team for assigned activities
- Is responsible for any assigned US applicable Risk Management Plan 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 Digital Media etc.)
- Participate in relevant crisis management activities within the scope of Ascendis PV group
Requirements
Competencies Identified for success:
- Works effectively independently and collaboratively
- Strong 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 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
Education Experience and Other Requirements:
- Bachelors 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 8 years recent experience in Pharmacovigilance
- Expert knowledge of 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
The estimated salary range for this position is $185-205K/year. 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
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.
Required Experience:
Director
Employment Type
Full-Time
