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 through surveillance, signal detection, validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

Responsibilities

Support 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; Ensure safety in one or more products through surveillance, signal detection, validation and assessment; Interpret regulations related to pharmacovigilance and support all patient safety activities; Understand and apply pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance; Conduct safety surveillance for pharmaceutical / biological / drug-device combined products; Contribute to the authorship of key pharmacovigilance documents, including medical safety assessments, regulatory responses and risk management plans; Apply current regulatory guidance for safety surveillance and authorship of PV documents; Analyze and interpret aggregate safety data and communicate analysis and interpretation to cross-functional teams; Write, review and provide input on technical documents; Lead the strategy for periodic reports (PSUR's, PADER's etc.); Oversee safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing; Lead and implement risk management strategy for assigned products

Requirements

MD / DO with 2+ years of residency with patient management experience; 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

Nice to have

Master Public Health

Benefits

Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees; Eligible to participate in long-term incentive programs