Senior Medical Director, Pharmacovigilance

Location
Working from Home
Posted
Jan 14, 2022
Ref
4913742003
Required Education
Masters Degree/MBA
Position Type
Full time

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.

 

Position Summary

Arvinas has an exciting opportunity for a Senior Medical Director, PV, who  will be responsible for global medical surveillance for the Arvinas marketed and/or investigational products assigned to him/her, including review and analysis of safety data from clinical trials and from post-marketing sources, providing medical expertise, the identification and investigation of safety signals, management of benefit-risk profile for assigned products and review and authoring of aggregate reports and safety sections of submission documents. S/he will be responsible for keeping upper management informed of safety issues. This is a critical role to ensure safety of patients taking Arvinas investigational and marketed products. 

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. This position may require minimal travel.

 

Principal Responsibilities

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

  • Maintains expert knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance.
  • Responsible for Individual Case Safety Report (ICSR) review when applicable. Ensures completeness and accuracy of safety information in individual case reports through assessment of seriousness, expectedness, and causality, coding, review of narrative summary and providing case comments; provides medical inquiries for follow-up.
  • Attends cross functional and project specific team meetings to provide PV medical expertise.
  • Responsible for safety signal detection activities for assigned products and discusses safety signals as needed at the Safety Management team (SMT).
  • Responsible for contributing to and review of aggregate reports (DSUR, PSUR, RMP, ad-hoc safety reports) including but not limited to providing expert medical opinion. Drafts the appropriate safety sections as well as Risk/benefit sections for aggregate reports and applicable submission documents.
  • Provides medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc.
  • Chairs the SMT and works effectively with all cross functional stakeholders (internal and external) to discuss and manage all new emerging safety signals from post-marketing and clinical trials environment.  
  • Exhibits good communication and fosters relationships with cross functional stakeholders on all pharmacovigilance related issues.
  • Responsible for the maintenance and updating of benefit-risk profile for assigned products through product lifecycle.
  • Contributes and reviews safety sections of study reports, protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling.
  • Leads internal PV meetings (SMT, etc.) based on specific topics. 
  • Typically assigned work of a more complex nature and/or global products that are marketed with risk management programs.

 

 

Qualifications

  • Minimum of 6 years of experience in a Pharmacovigilance/Drug Safety environment with substantial experience in managing adverse event and SAE processing, medical surveillance and risk management, signal detection, on a global basis within the pharmaceutical industry.
  • Demonstrated leadership in medical surveillance issues and regulatory environment.
  • Knowledge of principles of epidemiology and statistics as relates to PV deliverables.
  • Experience with the use of global safety databases.
  • PV operational experience a plus
  • The candidate should have extensive knowledge of ICH/FDA guidelines for GCP and Clinical and post-marketing Safety Reporting.
  • Highly developed skills in verbal and written communication, planning, organization, with extensive knowledge of the investigational clinical study and post-marketing setting.
  • Expert understanding of the drug development process.
  • Ability to work in a highly organized team environment.
  • Demonstrated decision-making and problem solving skills coupled with a can-do attitude.
  • Ability to successfully lead and/or to manage and prioritize multiple critical issues simultaneously.
  • Attention to detail with a highly consistent focus on quality.
  • Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents.
  • Ability to respond to inquiries or complaints.
  • Ability to work with mathematical concepts such as probability and statistical measures.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical information and deal with several abstract and concrete variables.
  • Experience with drug safety management tracking tools and electronic and safety databases.
  • Excellent PC skills including MS Office products (Word, Excel, and PowerPoint).

 

Education

  • Medical degree (MD), or DO. 
  • An oncology board certification is a plus, but not required

 

#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