Skip to main content

This job has expired

You will need to login before you can apply for a job.

Director, Pharmacovigilance Operations

Employer
Arvinas Inc.
Location
New Haven, CT
Start date
Jun 15, 2022

View more

Job Details

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.

 

Position Summary

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.

 

Principal Responsibilities

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. 

Qualifications

  • 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

Education

  • Bachelor’s degree in healthcare related field required, such as R.N., R.Ph., or PharmD (preferred).

 

#LI-Remote

 

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   

Company

At Arvinas, we’re leading the creation of an entirely new way to treat disease through therapies that target and degrade disease-related proteins. We are a clinical-stage biopharmaceutical company focused on developing new therapeutics for cancers and other difficult-to-treat diseases. Our proprietary PROTAC® protein degraders, or proteolysis-targeting chimeras, work by harnessing the body’s own natural protein disposal system to degrade and remove disease-causing proteins.

Our leading programs are focused on high-value targets in cancer, including the androgen and estrogen receptors associated with prostate and breast cancers, respectively. Our hope is to unlock the full potential of PROTAC protein degradation by developing our own robust pipeline and by partnering with the world’s leading drug development companies.

QUALITY BENEFITS
Designed with health and wellness in mind, employees and their families are eligible for:

  • Medical, dental, and vision options, including a generous company contribution into an HSA
  • Paid maternity and paternity leave
  • FSA, HSA, Healthcare, and Dependent Care accounts
  • Company provided life insurance and short/long-term disability coverage
  • Additional voluntary benefits including critical illness, hospital care and more

COMPENSATION & EQUITY
Central to our organization is attracting, retaining and engaging the best and brightest by sharing in the success of our organization:

  • Competitive salaries and an annual incentive program
  • 401K matching program with immediate vesting
  • Eligibility for long-term equity incentives upon hire and annually

TIME OFF
We believe it’s important to relax, unwind and enjoy life’s moments:

  • Paid vacation
  • A year-end office closure
  • Observed company holidays
  • Paid sabbatical upon 5 years’ tenure

We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. We take our work very seriously, but we also ensure we’re having fun while doing it. We embrace the freedom to pursue innovation, think creatively, and give back. We care about each other, celebrate our accomplishments, and rise up to encourage our colleagues through challenges. If you think one of these open positions might be a fit, we’d love to hear from you.

Company info
Website
Location
5 Science Park
395 Winchester Ave
New Haven
Connecticut
06511
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert