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Aevi Genomic Medicine, Inc. is dedicated to translating genetic discoveries into novel therapies. Driven by a commitment to patients, and guided by genomic insights, we strive to help patients navigate through the complexities of their disease. If you are looking for an opportunity to be part of building a fast-paced, collaborative, scientifically-disciplined team, then this is a great time to join Aevi to make a difference in the lives of children and adults with pediatric-onset diseases.

Job Openings >> Director, Pharmacovigilance
Director, Pharmacovigilance
Summary
Title:Director, Pharmacovigilance
ID:1008
Department:Research and Development
Description
 

Role:

Reporting to our Chief Scientific Officer, this position is responsible for the development and compliance of our pharmacovigilance (PV) system to ensure patient safety, full regulatory compliance, and timely flow of drug safety information to clinical teams and senior management.

  • Ensures that Aevi Genomics maintains a regulatory compliant pharmacovigilance system.
  • Serves as the responsible pharmacovigilance and clinical safety contact for vendors, contractors and business partners.
  • Ensures that applicable vendors maintain regulatory compliant pharmacovigilance systems and clinical safety management processes. The scope of services provided by vendors may include: clinical trial management, clinical adverse event collection and management, clinical serious adverse event reconciliation, spontaneous case processing, expedited regulatory report submissions, medical information, product distribution and product complaint management.
  • Facilitates the interaction between CROs and contracted pharmacovigilance vendor(s) in managing serious adverse events and expedited report submissions.
  • Maintains accurate documentation of the Aevi Genomic Pharmacovigilance System.
  • Crafts, manages and maintains pharmacovigilance agreements with business partners. These agreements span bilateral responsibilities for communicating postmarketing, clinical safety and regulatory information. Ensures appropriate interaction between Aevi Genomic’s pharmacovigilance or clinical safety vendors and business partners.
  • Ensures that business partners maintain regulatory compliant pharmacovigilance systems and that a quality control system to monitor pharmacovigilance activities is in place.
  • Crafts and maintains Aevi Genomics’ pharmacovigilance and clinical safety-related procedures and guidelines and provide training to vendors and employees as needed.
  • Ensures that Aevi Genomics maintains a regulatory compliant pharmacovigilance system.
  • Serves as the responsible pharmacovigilance and clinical safety contact for vendors, contractors and business partners.
  • Ensures that applicable vendors maintain regulatory compliant pharmacovigilance systems and clinical safety management processes. The scope of services provided by vendors may include: clinical trial management, clinical adverse event collection and management, clinical serious adverse event reconciliation, spontaneous case processing, expedited regulatory report submissions, medical information, product distribution and product complaint management.
  • Facilitates the interaction between CROs and contracted pharmacovigilance vendor(s) in managing serious adverse events and expedited report submissions.
  • Maintains accurate documentation of the Aevi Genomic Pharmacovigilance System.
  • Crafts, manages and maintains pharmacovigilance agreements with business partners. These agreements span bilateral responsibilities for communicating postmarketing, clinical safety and regulatory information. Ensures appropriate interaction between Aevi Genomic’s pharmacovigilance or clinical safety vendors and business partners.
  • Ensures that business partners maintain regulatory compliant pharmacovigilance systems and that a quality control system to monitor pharmacovigilance activities is in place.
  • Crafts and maintains Aevi Genomics’ pharmacovigilance and clinical safety-related procedures and guidelines and provide training to vendors and employees as needed.

Requirements:

  • BS degree degree in a health care discipline, ie MD, BSN. Advanced degree preferred
  • 10 years relevant experience in clinical and postmarketing pharmacovigilance and clinical safety
  • Ability to travel
  • Strong knowledge of U.S. and E.U. pharmacovigilance regulations
  • Experience in leading projects
  • Management experience
This opening is closed and is no longer accepting applications
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Aevi Genomic Medicine, Inc. offers its employees a competitive benefits and compensation plan.

Aevi Genomic Medicine, Inc. is an Equal Opportunity Employer.