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Group Medical Director, Pharmacovigilance
4 months ago
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionPurpose:
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.
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Qualifications
Qualifications:
- MD/DO with clinical experience of at least 3 years
- Minimum of 3 years of relevant clinical development or PV experience in Psychiatry
- Minimum 5-7 years experience in drug safety and/or a related discipline in the pharmaceutical industry
- Minimum 3 years of clinical experience in Psychiatry required
- 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
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 short-term incentive programs.
- 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.
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.
