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Open Positions: Associate Director, PV Sciences

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

Incumbent is responsible for supporting the Pharmacovigilance (PV) Sciences function under the guidance of the Director, PV Sciences and having oversight of medical surveillance and risk management activities for their assigned products in collaboration with the PV physicians. The incumbent works cross-functionally with key internal and external key leaders and external resources on pharmacovigilance-related matters.

This position reports to the Director, Pharmacovigilance Sciences and can be located at our headquarters in New Haven, CT or work with a hybrid or remote arrangement within the United States.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

  • Accountable for contributing to pharmacovigilance aggregate reports (e.g. DSUR, PBRER)
    • Collaborates with PV physicians and key stakeholders to request/receive applicable sections of the report.
    • Provides training and guidance to other functions to address ad hoc questions and issues.
    • Ensures timely submission to relevant health authorities and other external stakeholders.
  • Provides safety information as needed for study reports, protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA, Health Authority requests and product labeling.
  • Collaborates with the PV physicians to ensure all information is available to allow for informed medical review and benefit-risk assessment of team’s assigned product(s).
  • Provides technical and scientific support for safety surveillance and signal detection activities for assigned product(s) or therapeutic area, including literature review.
  • Responsible for ensuring that routine Safety Management Team (SMT) meetings are scheduled for assigned product(s) and overseeing outcomes.
    • Ensures appropriate stakeholder representation and input at SMT.
    • Ensures all data is appropriately compiled and presented at SMT for team review
    • Liaises with SMT chair to facilitate communication and support for decisions resulting from the SMT (e.g. update of RMPs, labeling, regulatory notifications).
  • Responsible for contributing to the development and maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities for team’s assigned products in conjunction with QPPV vendor.
    • Provides oversight to ensure that all RMP commitments are efficiently tracked.
    • Provides oversight to ensure that RMP is updated as needed.
  • Collaborates with internal and external stakeholders outside of PV. Represents PV department in cross-functional meetings and additional activities to support clinical developmental programs.
  • Provides guidance to any Drug Safety Monitoring Board if applicable.
  • Demonstrates subject matter expertise and understanding of all clinical and post-marketing activities and PV requirements for team’s assigned products.
  • Evaluates and improves current processes, as needed, to enhance medical surveillance and risk management process to ensure best practices.
  • Participates in audit preparedness activities and provides support during regulatory inspections in collaboration with team members.
  • Establishes good communication and fosters relationships with all stakeholders including PV Vendors, and Arvinas partners on all pharmacovigilance related issues.
  • Contributes to internal and external PV meetings based on specific topics.
  • Provides guidance, training, and oversight to pharmacovigilance vendor supporting pharmacovigilance activities, as needed.
  • Participates in new study initiation to ensure PV requirements are met including but not limited to: safety reporting, query resolution, SAE reconciliation, un-blinding process, and safety reporting training.

Qualifications

  • Minimum of 6 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment.with focused experience in signal detection, safety surveillance, risk mitigation and risk management.
  • Experience in signal detection, safety surveillance, risk mitigation and risk management.
  • 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).
  • Experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality a plus.
  • 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.

Education

  • Bachelor’s degree in health-related discipline or equivalent required. RN, R.Ph., or Pharm D. degree is highly 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

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