Associate Director, Global PV Operations (00028)
In this role, you will be responsible for:
Ensure that adverse events from spontaneous cases, solicited cases, and from studies and programs involving Ascendis products are collected, reported, and handled in accordance with global/local regulatory requirements and company policies. Function as a Subject Matter Expert (SME) with regard to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Ascendis products. Participate in the conduct of Sponsored and Investigator Initiated Trials for Ascendis products. Review study documents, including but not limited to Study Protocol, Safety Management Plans (SMPs), Data Management Plans, etc. Support SAE Reconciliation activities for assigned studies as applicable. Exercise responsibility for study classification (i.e., interventional studies, non-interventional studies, Post Approval Safety Studies (PASS), etc.). Function as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff. Support 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.). Ensure vendor oversight under the guidance of the Head of Global PV Operations by contributing to the Vendor Quality Agreements. Liaise with functional units in order to identify Market Research and Patient Support programs (MAPs). Provide strategic input on the conduct of MAPs to ensure compliance with PV requirements. Monitor GVP and Patient support program service providers in order to identify areas of risk and develop strategy and action plans to ensure compliance. Work closely with Ascendis GCP/PV Compliance team and Commercial organization as required to ensure oversight of GVP and PSP, and SPs. Through coordination with the Ascendis GCP and PV Compliance team, provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits, and oversee and support the implementation of CAPAs as necessary. Exercise responsibility for any assigned US applicable Risk Management Plan Implementation Coordination activities and associated tracking as necessary. Participate in relevant crisis management activities within the scope of Ascendis PV group.
A reasonable estimate of salary range for a new employee to be offered this role would be between $190,000-$215,000/year, which would be adjusted based on each employee's geographic location for 40 hours/week (Mon-Fri).
FOR THIS ROLE, WE ARE LOOKING FOR INDIVIDUALS THAT HAVE:
Master’s degree in Health Care Management or a related field and 8 years of experience in the job offered or 8 years of Pharmacovigilance experience. Experience must include 5 years of experience in: the development of strategy, and the design and implementation of programs; assuring appropriate review of all SUSAR SAE cases for regulatory reporting purposes; acting as the PV/Drug safety subject matter expert on cross-functional clinical studies; and reviewing and assisting safety related activities associated with new drug applications/regulatory filings. Experience must also include 1 year of experience in: performing case processing for clinical studies, literature, and MHRA; and triaging ICSRs to determine whether they qualify for expedited reporting.
ABOUT ASCENDIS PHARMA, INC.
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and established advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with offices in Heidelberg, Germany, Princeton, New Jersey, Redwood City, and Palo Alto, California.
Ascendis is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action-Employer, making decisions without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, marital status, protected veteran status or any other protected class.
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
#LI-DNI and #IND-DNS
- Medical insurance
- Vision insurance
- Dental insurance
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
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