Group Medical Director, Pharmacovigilance & Patient Safety (Psychiatry)

at  AbbVie

QUALIFICATIONS:

• MD/DO with clinical experience of at least 3 years
• Relevant clinical development or PV experience in psychiatry is preferred
• Minimum 5-7 years experience in drug safety and/or a related discipline 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
• Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
• Ability to lead and influence 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
  AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status

PURPOSE:

Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and supports one or more psychiatry products as the PST Lead. 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 and set the strategy for 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 analyses and interpretations to cross-functional teams
• Effectively write, review and provide input on technical documents independently. Contribute to the strategy for periodic reports (PSUR’s, PADER’s etc.)
• Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing.
• Responsible for implementing risk management strategies for assigned products
• Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.
• Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program and for overseeing approval related activities.