Job Description

Serve as Indication Product Safety Lead for one or more products or product indications under the direction of the Therapeutic Area (TA) Lead and Global TA. Ensuring safety of one or more products through the product lifecycle (e.g. 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

Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products

Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports.

Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents

Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management

Independently write, review, and provide input on technical documents

Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.g. PSURs,DSURs, PADERs and Safety sections of the IBs)

Lead and set the strategy, in collaboration with the development medical lead of study protocols and informed consents

Responsible for implementing risk management strategies for assigned product

Proactively engaging, inspiring, coaching and mentoring team members and colleagues

Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Frequent to continuous computer usage (greater or equal to 50% of the workday) is required