Medical Director- Early Development Oncology
Florham Park, NJ - USA
Job Summary
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
Qualifications :
- 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
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 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 Companys sole and absolute discretion unless and until paid and may 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more