Medical Director, Oncology, Global Patient Safety

About the role

Responsible for supporting the Product Safety Lead (PST) in ensuring safety in one or more products through surveillance, signal detection, validation and assessment. Interpreting regulations related to pharmacovigilance and supporting all patient safety activities.

Responsibilities

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Safety surveillance for pharmaceutical / biological / drug–device combined products
• Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyze and interpret aggregate safety data and communicate these analyses and interpretations to cross-functional teams
• Under the guidance of PST Lead, write, review and provide input on technical documents

Qualifications

• MD / DO with 2+ years of residency with patient management experience required
• Master of Public Health is preferred in addition to MD / DO
• Effectively analyze clinical data and epidemiological information required
• Effectively write technical documents with direction
• Work collaboratively in a team environment and be self-starting and able to work independently
• Ability to effectively present recommendations / opinions in group environment
• Fluency, both written and oral, in English