Sr Medical Director, Medical Safety Evaluation, Immunology
Sr Medical Director, Medical Safety Evaluation, Immunology
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Serve as Indication Product Safety Lead for one or more products under the direction of Group Medical Director Medical Safety Evaluation. Supporting assigned product with safety expertise through its lifecycle (including during the time of clinical development marketing registration and post marketing) Interpreting summarizing and presenting safety data in compliance with the regulatory guidelines.
Responsibilities:
Understanding and application of pharmacology chemistry and non-clinical toxicology to effectively conduct safety surveillance
Responsible for safety surveillance for pharmaceutical / biological / drug device combined products
Leading setting the strategy and when appropriate authoring the key documents with safety data including but not limited to medical safety assessments parts of submission dossier and regulatory responses.
Applying current regulatory guidance as appropriate for safety surveillance
Analyzing interpreting and summarizing aggregate safety data and communicating these analysis and interpretation to cross-functional teams and senior management
Independently writing reviewing and providing input on technical documents
Providing oversight leading the strategy as well as authoring when applicable the key sections for periodic reports (e.g. PSURs DSURs PADERs and Safety sections of the IBs)
Leading and setting the strategy in collaboration with the development medical lead of study protocols and informed consents
Defining and implementing risk management strategies for assigned product/indication
Proactively engaging inspiring coaching and mentoring team members and colleagues
Co-authoring publications and developing and growing as a safety leader
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Qualifications :
MD / DO with 2 years of residency with patient management experience; Master Public Health is preferred in addition to MD / DO not required
5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry or other relevant experience
Effectively analyze and guide analysis of clinical data and epidemiological information
Strong communicator who is able to effectively present recommendations / opinions in group environment both internally and externally
Write review and provide input on technical documents
Able work collaboratively and lead cross-functional team
Formulates independent decisions
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 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 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 :
Full-time
Employment Type
Remote
