Medical Director, Neuroscience, Global Patient Safety

About the Role

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.

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.

Qualifications

• MD / DO with 2+ years of residency with patient management experience. Master Public Health is preferred in addition to MD / DO, not required.
• 2-5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
• Effectively analyze and guide analysis of clinical data and epidemiological information.
• Effectively present recommendations / opinions in group environment both internally and externally.
• Write, review and provide input on technical documents.
• Work collaboratively and lead cross-functional teams.
• Ability to lead cross-functional teams in a collaborative environment.
• Fluency, both written and oral, in English.
• Evaluate and make independent decisions.
• Ability to work effectively in the situation of uncertainty and complexity, ability to multitask.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Eligibility to participate in long-term incentive programs

Pay

The compensation range is based on the job grade for this position and depends on many factors including geographic location. This range may be modified in the future. 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.