Associate Medical Director, Medical Safety Evaluation/Medical Director, Medical Safety Evaluation

Pharmacovigilance Product Safety Team Leader

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.

Purpose:

Supporting the Product Safety Leads (PSTLs) and potentially leading one or more products as the PSTL under the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance, signal detection, validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

Responsibilities:

Understands and applies he pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance

Safety surveillance for pharmaceutical / biological / drug device combined products, contributes to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans

Applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents

Analyzes and interprets aggregate safety data and communicate these analysis and interpretation to cross-functional teams

Effectively writes, reviews and provides input on technical documents.

Leads the strategy for periodic reports (DSURs, PSURs, PADERs etc.)

Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials

Leads and implements risk management strategy for assigned products

Key Stakeholders:

Group Medical Director, Executive Director, TA head, PST Lead, Analytics / Data Scientists, Project Management and Data Management, Clinical Development, Preclinical Safety, Precision Medicine

Qualifications:

MD / DO with 2+ years of residency with patient management experience

2 4 years of Pharmacovigilance experience in the pharmaceutical industry

Effectively analyze and guide analysis of clinical data and epidemiological information required

Effectively write technical documents with direction

Ability to effectively present recommendation / opinions in a group environment

Fluency, both written and oral, in English

Self-starting and can work independently

Work collaboratively and lead cross-functional teams

Additional Information:

• 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 an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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