Open Positions: Senior 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 two clinical-stage programs: ARV-110, which is being developed as a potential treatment 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 200 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 Senior Director, Pharmacovigilance Operations to provide direction and strategy for the PV operational function within the Arvinas Pharmacovigilance department. This includes internal and external safety representation to the development teams and oversight of the activities of the PV operational employees. 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 Vice President of Pharmacovigilance and can be based in New Haven, CT, or can be performed in a hybrid or remote work arrangement.
Key responsibilities of this role include, but are not limited to:
- Setting the direction and strategy for operations within the PV department.
- Creates and maintains oversight of all PV processes.
- Provides resource management for PV operations.
- Reviews and provides input in clinical trial protocols, ICF, IB, and other clinical study-related documents impacting PV.
- Leads initiatives for process creation and improvement, and collaborates with other cross functional groups, to develop, implement and maintain processes that are compliant with global PV regulations.
- Prepares slides for, participates in and presents at Safety Management team meetings (SMTs
- Represents PV operations in cross-functional meetings and collaborates with internal and external stakeholders outside of PV.
- Leads and creates PV process creation and improvement activities to enhance all PV operational, medical surveillance and risk management process to ensure best practices.
- Develops operational guidance to the PV department to ensure that best practices are followed and processes are streamlined.
- Accountable for the overall project management responsibility for compiling pharmacovigilance aggregate reports (e.g. DSUR), and participates in review of all aggregate reports.
- Takes a leadership role representing PV operations during audits and inspections and oversees GPV readiness. Participates in audit preparedness activities and serves as subject matter expert regarding PV operations during regulatory inspections in collaboration with PV team members.
- Creates and leads training for all PV processes and provides oversight to pharmacovigilance vendors and CRO’s supporting pharmacovigilance activities.
- Leads and establishes a governance structure between Arvinas and PV vendors and provides the oversight for work performed.
- Oversees and contributes to work performed by pharmacovigilance vendor(s).
- Ensures the consolidation of vendors performing PV activities to streamline PV processes and efficiencies
- Establishes KPIs and monitors the vendors for all work performed for PV department.
- Ensures PV vendors have been trained and are provided with all necessary materials.
- Coordinates the PV operational budgets, including MSA and SOW with PV vendors and responsible for contracts, MSAs, CDAs, SOWs, invoices and payments for work provided by PV vendors for review and approval by the VP of PV.
- Authors new or revised SOPs, work instructions, guidance in regards to Vendor Oversight and QST activities in collaboration with other PV team members and other cross-functional team members as applicable.
- Responsible for the Quality control within PV including compliance, best practices, and continuous process improvements.
- Oversees the development of SDEAs or pharmacovigilance agreements with Arvinas partners and vendors for specific obligations for safety data exchange and reporting.
- Minimum of 8 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 3 of which were spent in a leadership/managerial role within pharmacovigilance sciences.
- Experience with signal detection, safety surveillance, literature review, risk mitigation and risk management from a PV operational perspective.
- Experience directly managing people and/or leading a cross-functional team.
- Expert knowledge of relevant food and drug administration (FDA), European union (EU) and international conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
- Extensive working knowledge of medical terminology and medical dictionary of regulatory activities (MedDRA). Demonstrated hands-on experience identifying, developing, and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
- Experience leading and contributing to PV process improvements and inspection readiness, Health Authority audits, standardization of safety reports, SDEA negotiations, vendor management, etc.
- Experience with oversight of all contracts with external parties including SDEAs, budgets, MSAs, invoicing and payments for services provided
- Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
- Basic knowledge of common data processing software (Excel, Powerpoint, Microsoft Word, Business Objects.) Strong knowledge of safety database systems.
- Strong organizational skills, including the ability to prioritize independently with minimal supervision.
- Ability to assess resource needs and adapt accordingly.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members.
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Ability to influence without direct authority.
- Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
- Ability to write reports, business correspondence, and procedures.
- Ability to effectively present information and respond to questions from internal and external clients, both domestic and international.
- Bachelor’s degree in health-related discipline, RN, R.Ph., or Pharm D. degree is highly 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