Open Positions: Director, Pharmacovigilance Operations
Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes three clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766, which are being developed as potential treatments for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 350 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
Arvinas has an outstanding opportunity for a Director, Pharmacovigilance Operations. This role contributes to the safety and benefit-risk evaluations for the developmental clinical programs. The selected candidate will lead PV vendor oversight including establishing clear key performance indicators, ensuring efficiency in the processes, and ensuring case level quality of the work performed. S/he oversees overall workflow compliance, health authority submissions, PV related CAPAs and leads the governance structure between Arvinas and PV vendors. The incumbent works cross-functionally as needed with key stakeholders and external resources on pharmacovigilance-related matters for business integration activities. Provides oversight of all contracts with external parties including SDEAs, budgets, MSAs, invoicing and payments for services provided. Contributes to the development or revision of existing PV processes.
This position reports to the Senior Director of Pharmacovigilance Operations and can be remote, hybrid or located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- Oversee and contribute to work performed by PV vendor, including establishing KPIs and monitoring vendor(s) for all work performed for PV department.
- Create and/or assist with creating and/or leading training for all PV processes and providing oversight to PV vendors and CROs supporting PV activities.
- Provide training for PV vendors.
- Assist with creation and/or review of MSA and SOW with PV vendors as well as contracts, MSAs, CDAs, SOWs, invoices and payments for work provided by PV vendors for review and approval by the Senior Director of PV operations and/or VP of PV.
- Author and/or review SOPs, work instructions, and guidance regarding Vendor Oversight in collaboration with other PV team members and other cross-functional team members as applicable.
- Oversee the consolidation of vendors performing PV activities to streamline PV processes and efficiencies.
- Assist the Senior Director of PV Operations with processes, and initiatives, including but not limited to, audit/inspection readiness, SDEA/PVAs for partners, reviewing clinical study-related documents impacting PV, represent PV operations in collaboration with other functions and/or presentations as needed.
- Minimum 7 years of progressively responsible PV experience in a pharmaceutical, biotechnology or related environment, at least 5 of which were spent in a leadership/managerial role within PV Operations.
- Expert knowledge in PV vendor oversight and working with Alliance Partners and managing PVAs/SDEAs
- Expert knowledge of relevant FDA, EU, and ICH guidelines, including inspections
- In depth knowledge of monitoring HA submissions, CAPAs and relationships between PV vendors
- Experience with signal detection, safety surveillance, literature review, risk mitigation, and risk management from a PV operational perspective a plus.
- Experience with PV aggregate reports (e.g., DSUR) a plus.
- Oncology experience a plus
- Excellent strategic decision-making and analytical skills
- Strong written and verbal communication skills
- Bachelor’s degree in healthcare related field required, such as R.N., R.Ph., or PharmD (preferred).
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com
Arvinas is an Equal Opportunity employer