Purpose :

Describes the primary goals, objective or function or outputs of this position. 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 neuroscience 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 safety strategy for regulatory submissions, including INDs, NDAs, and MAAs and the periodic reports (PSUR’s, PADER’s etc.)
• Oversight of safety surveillance and pharmacovigilance activities for neuroscience products in clinical trials and post marketing
• Lead and implement risk management strategy for assigned neuroscience products