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$185,000-205,000
Ascendis Pharma
Palo Alto, CA, USA
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ShareAscendis 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 Sr. Vendor Management Lead reports to the Head, Vendor Management within the Global Patient Safety (GPS) organization. Under the direction of the Head, Vendor Management 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 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 Vendor Management (example: Local PV agreements, CRMs, Digital Media etc.) Participate in relevant crisis management activities within the scope of Ascendis PV group Salary range: $185-205K/year DOE 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: 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 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 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.
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Massachusetts, USA