Senior Medical Director, Immunology, Global Patient Safety

Responsible for supporting the Product Safety Leads (PST) and potentially support one or more products as the PST Lead under the direction of the Therapeutic Area (TA) Lead and Global TA Head 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
Ability to effectively write, review and provide input on technical documents
Lead the strategy for periodic reports (PSUR’s, PADER’s etc.)
Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
Lead and implement risk management strategy for assigned products
MD / DO with 2+ years of residency with patient management experience and Master Public Health is preferred in addition to MD / DO but not required
2 – 4 years of Pharmacovigilance experience in the pharmaceutical industry
Effectively analyze and guide analysis of clinical data and epidemiological information
Effectively present recommendation / opinions in group environment
Write, review and provide input on technical documents
Self-starting and can work independently
Work collaboratively and lead cross-functional teams

Employment type
Full-time

Work arrangement
Hybrid