Medical Director Late Stage Oncology-Product Safety Team Lead Remote
Medical Director Late Stage Oncology-Product Safety Team Lead Remote
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
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 nonclinical 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 crossfunctional 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.
- 25 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 crossfunctional teams.
- Ability to lead crossfunctional 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 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 shortterm 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:
Yes
Employment Type :
Fulltime
Employment Type
Remote
