Group Medical Director, Product Safety Teams
1 month ago
Company Description
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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
Purpose:
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and 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 surveillanceResponsible for safety surveillance for pharmaceutical / biological / drug device combined productsLead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plansApply current regulatory guidance as appropriate for safety surveillance and authorship of PV documentsAnalyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teamsEffectively write, review and provide input on technical documents independently Oversight and responsibility for leading the strategy for periodic reports (PSURs, PADERs etc.)Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing Responsible for implementing risk management strategies for assigned productsProactively engaging, inspiring, coaching and mentoring team and colleaguesManages 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 hr day) is required Frequent to continuous computer usage (greater or equal to 50% of the workday) is required This role can be based anywhere in the United States, Canada, UK or Europe.Qualifications
MD/DO with 2+ years of residency with patient management experience.Minimum 5-7 years experience in drug safety or a related disciple in the pharmaceutical industryEffectively analyze and guide analysis of clinical data and epidemiological information.Effectively present recommendations/opinions in group environment both internally and externallyWrite, review, and provide input on technical documents. Work collaboratively and lead cross-functional teamsAbility to lead cross-functional teams in a collaborative environment.Fluency, both written and oral, in EnglishEvaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitaskRelevant clinical development or PV experience in Immunology is preferredDemonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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. US & Puerto Rico only - to learn more, visit
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