Senior Medical Director, Immunology, Global Patient Safety

Location: Northern

# Senior Medical Director, Immunology, Global Patient Safety North Chicago, IL Full-time Notify me about similar jobs

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Company Description
** About Abb Vie
** Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at   .

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Job Description 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

Qualifications MD / DO with 2+ years of residency with patient management experience and Master Public Health is preferred in addition to MD / DO but not required2 – 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