Purpose:
To lead Product Safety Teams (PST) and support one or more products as the PST Lead, ensuring that the safety profile of one or more products is adequately monitored and characterized throughout the product lifecycle (e.g., surveillance, signal detection and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

Location: Open for all other  AbbVie office locations in the US.

Responsibilities:
• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance.
• Responsible for safety surveillance for pharmaceutical / biological / drug –device combination products
• Lead, oversee, and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic safety reports (DSURs, PBRERs/PSURs, PADERs), etc.
• Lead and oversee safety surveillance and pharmacovigilance activities for products in clinical development and marketed products, applying current regulatory guidance as appropriate
• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams and regulatory authorities.
• Effectively and independently write, review, and present technical documents .
• Responsible for implementing risk management strategies for assigned products.
• Proactively engaging, inspiring, coaching and mentoring team and colleagues.