Medical Director, Immunology, Global Patient Safety

Responsible for supporting the Product Safety Lead (PST) in ensuring safety in one or more products to through surveillance, signal detection, validation and assessment. Interpreting regulations related to pharmacovigilance 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 analysis and interpretation 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 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 recommendation / opinions in group environment
Fluency, both written and oral, in English

Employment type
Full-time

Work arrangement
Hybrid