Medical Director, Late Stage Oncology-Product Safety Team Lead (Remote)

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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.

Purpose

Job Description

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.
  
  
  

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 ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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/visioninsurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
  
  
  

Note: No amount of payis considered to bewages 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys 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, 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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html