Global Pharmacovigilance Lead

1 week ago


New Providence, New Jersey, United States ADC Therapeutics SA Full time
Key Responsibilities
  • Leads pharmacovigilance activities of cross-functional project teams for developmental compounds and/or marketed products.
  • Develops, maintains, oversees, and executes comprehensive safety surveillance and signal detection plans for assigned products.
  • Authors safety sections and other relevant content for Investigator Brochures, Protocols, Informed Consents, and Clinical Study Reports.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree in sciences/pharmacy/nursing or related field.
  • RN, R.Ph., or Pharm D. degree is highly preferred.
  • 8+ years of proven pharmacovigilance experience, preferably in oncology.
  • Patient Safety and/or Clinical/Drug Development experience with proven track record in at least 3 areas: clinical drug development, post-marketing surveillance, MAA/BLA preparation, Periodic Safety Reports, and Risk Management Plans.


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