Senior Medical Director, Neuroscience, Global Patient Safety

About the role

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

Qualifications & Requirements

• MD / DO with 2+ years of residency with patient management experience and Master Public
• Health is preferred in addition to MD / DO but not required
• 2 - 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
• Work collaboratively and lead cross-functional teams

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.