Medical Director- Early Development Oncology

AbbVie; New Jersey; In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

AbbVie is seeking a Pharmacovigilance professional in the United States focused on safety surveillance and regulatory compliance. The role supports the Product Safety Lead in surveillance, signal detection, validation, and assessment across products, including immunology, oncology, neuroscience, and Allergan Aesthetics portfolio.

The position requires an MD or DO with residency experience, preferably with MPH, and strong English communication skills.

Competenze

• MD / DO with 2+ years of residency with patient management experience required.
• Master Public Health is preferred in addition to MD / DO
• Effectively analyze clinical data and epidemiological information required
• Effectively write technical documents with direction
• Work collaboratively in a team environment and be self-starting and able to work independently
• Ability to effectively present recommendation / opinions in group environment
• Fluency, both written and oral, in English

Mansioni

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Safety surveillance for pharmaceutical / biological / drug –device combined products
• Contribute to the authorship of 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 analysis and interpretation to cross-functional teams
• Under the guidance of PST Lead write, review and provide input on technical documents

Conoscenze

Clinical data analysis

Medical writing

Team collaboration

Formazione

MD/DO

Master of Public Health

Descrizione del lavoro

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, Xand YouTube.

Responsible for supporting the Product Safety Lead (PST) in ensuring safety in one or more products to through 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
• Safety surveillance for pharmaceutical / biological / drug –device combined products
• Contribute to the authorship of 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 analysis and interpretation to cross-functional teams
• Under the guidance of PST Lead write, review and provide input on technical documents

• MD / DO with 2+ years of residency with patient management experience required
• Master Public Health is preferred in addition to MD / DO
• Effectively analyze clinical data and epidemiological information required
• Effectively write technical documents with direction
• Work collaboratively in a team environment and be self-starting and able to work independently
• Ability to effectively present recommendation / opinions in group environment
• Fluency, both written and oral, in English

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, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein 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 employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.

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