Pharmacovigilance Scientist

New

Skills

Ich Guidelines Oncology

Provide PV life-cycle support for assigned products and participate in clinical study teams. Represent PV as PV lead in cross-functional teams and with CROs. Perform ongoing ICSR quality review per SOPs and study Safety Plans. Perform signal detection and evaluation; deliver safety analyses and reports. Author DSURs and respond to health authority safety queries. Collaborate with Clinical/Medical teams to communicate safety concerns and escalate issues.

Key Responsibilities
  • Provide PV life-cycle support for assigned products
  • Represent PV as PV lead in cross-functional teams and with CROs
  • Perform ongoing ICSR quality review per SOPs and study Safety Plans
  • Perform signal detection and evaluation
  • Author DSURs and respond to health authority safety queries
Required Skills & Qualifications
  • MS, PhD, or PharmD
  • 5+ years PV/drug safety in early development
  • Immunology/oncology focus; CART-cell or T cell engagers preferred
  • Ability to use Argus safety system for case review and simple queries
  • Knowledge of ICH, EMA GVP, FDA IND/NDA, CIOMS

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Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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