Head, Global PV Operations (00024)

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.

In this role, you will be responsible for:

Responsible for assigned Pharmacovigilance (PV) activities/projects and working collaboratively with other teams within Ascendis. Through coordination with Ascendis GCP and PV Compliance team, provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits. Function as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff. Provide advice to address queries involving safety reporting for both Ascendis sponsored and investigator-initiated studies when higher level input is required. Ensure that processes are adhered to that support on-time and appropriate ICSR submissions. Provide pharmacovigilance expertise to Ascendis or CRO/Vendor staff as needed. Ensure SP/vendor oversight under the guidance of Senior Director, PV Safety Evaluation and QPPV by developing and implementing SP Oversight plans as required by Ascendis PV SOPs. Work with QPPV and other PV team members to ensure that PSP programs are tracked in appropriate tracking tools. Raise or increase awareness, knowledge, and understanding of pharmacovigilance requirements by conducting internal education/training sessions with business partners. Monitor GVP and PSP SPs to identify areas of risk and develop strategy and action plans to ensure compliance. Oversee and support implementation of CAPAs as necessary. Address issues with business units and support their resolution in case of non-compliance. Work closely with Ascendis GCP/PV Compliance team to ensure oversight of GVP and PSP SPs. A reasonable estimate of salary range for a new employee to be offered this role would be between $200,000 - $280,000. M-F, 40 hours/week.

Requirements

FOR THIS ROLE, WE ARE LOOKING FOR INDIVIDUALS THAT HAVE:

Minimum Requirements:

Master's degree in Biology, Medicine, Life Sciences, or a related field and 8 years of experience in the job offered or 8 years of Pharmacovigilance experience in the management of a drug safety organization. Experience must include 5 years in/with: working with Safety Databases, including ARIS Suite, ARISg, and/or ARGUS; performing Study Management; working with SUSARs; performing End of Study Reconciliation; adhering to FDA safety regulations, ICH Guidelines, and global safety regulations; participating in Vendor Selection (RFP Process); participating in Audits and Inspections; and drafting, reviewing, and approving Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreements (SDEA).

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

Benefits

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