Responsible for supporting the Product Safety Lead (PST) 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
• Under the guidance of PST Lead write, review and provide input on technical documents