Associate Director, PV Operations - Job ID: 1099

The Associate Director, Global PV Operations reports directly to the Head of Global PV Operations. Under the direction of the Head of Global PV Operations, is responsible for all assigned Ascendis Drug Safety PV Operations related activities for all products in the Ascendis portfolio. This individual has accountability for the assigned PV Operations activities in Ascendis.

Support Study Management Teams (SMTs) as an active member representing PV Operations team.

• Participate in the conduct of Sponsored and Investigator Initiated Trials for Ascendis products
• Responsible for the review of study documents including but not limited to Study Protocol, Safety Management Plan (SMPs), Data Management Plan etc.
• Support SAE Reconciliation activities for assigned studies as applicable
• Responsible for study classification (i.e. interventional studies, non[1]interventional studies, Post Approval Safety Studies (PASS) etc.)

Oversees the PV 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
• Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Ascendis products
• Ensures that adverse events from spontaneous cases, solicited cases and from studies and programs 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 Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff
• Ensures processes are adhered to that support on-time and appropriate ICSR submissions
• Supports the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report, etc.)
• Provides pharmacovigilance expertise to Ascendis or CRO/Vendor staff when needed

Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs) and other Service Providers (SPs) vendors. These activities include, but is not limited to:

• Ensuring SP/vendor oversight under the guidance of Head of Global PV Operations by contributing to the Vendor Quality Agreements
• Liaise with functional units to identify Market Research and Patient Support programs (MAPs)
• Provide strategic input on the conduct of MAPs to ensure compliance with PV requirements
• Accountable for maintaining oversight over Source data quality check [SDQC] activities and/ or Case Transmission Verification (CTV) activities and ensure tracking and timely completion
• Raises 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

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 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 Global PV Operations (example: Local PV agreements, CRMs, Digital Media etc.)
• Participate in relevant crisis management activities within the scope of Ascendis PV group

Requirements

• Master's degree in a health care field with relevant pharmaceutical industry experience in drug safety required
• Minimum of 8 years recent experience in Pharmacovigilance required
• 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
• New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
• Estimated Salary: $185k-$215k/year DOE

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short Term & Long Term Disability
• Training & Development
• Work From Home
• Free Food & Snacks
• Wellness Resources
• Stock Option Plan