Employment Type : Full-Time
Palo Alto, California, United StatesDevelopment Operations, Pharmacovigilance Description The Manager / Sr. Manager 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. Key Responsibilities Support Study Management Teams (SMTs) as an active member representing PV Operations team. Additional activities may include but is not limited to: Competencies Identified for success: Job Type: Full-time
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-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
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
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
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
Requirements
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 3 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