Associate Director - Global PV Operations

2 days ago

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Ascendis Pharma

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We've got making a difference for patients down to a science

Endocrinology • Oncology • Drug Development • Innovation • Globalization

501 - 1000

Description

• 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, noninterventional 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

Benefits

• Medical insurance • Vision insurance • Dental insurance • 401(k) • Paid maternity leave • Paid paternity leave • Commuter benefits • Disability insurance