Risk Management Consultant

4 weeks ago

West Point, United States AA2IT Full time
Job DescriptionJob Description

• Part time role(20hrs/week). • Can be remote/hybrid/onsite(depending upon candidate's need-all options are open) • Reporting time: Any time between 9a-3pEST is needed. • Candidate can break his 20hrs/week over a period of 5 days in a week. • Should be available for meetings. • Assignment could be extended beyond 6 months.

Education: • Graduate degree in nursing, health sciences, pharmacology, epidemiology, public health, or other relevant health-related fields. • Advance degree like Pharm-D, PHD, MD's

-preferred. Experience:

• At least 3 years of experience in clinical, pharmacological, or related field of expertise.

• Excellent writing and communication skills are a must.

• Experience in data analysis or the interpretation of adverse experience information is a plus.

• Candidates will not be seeing the patients.

• The candidates would not be required to have an “active” license.

Must have:

• Previous experience in CRO's /academia would be good

• Industry experience is preferred.

• Aggregate review of adverse events reports.

• Review of Individual case safety reports (ICSR).

• Review of adverse event narratives.

• Review of social medial post containing adverse events.

• Therapeutic Areas: Oncology, general medicine. But other Therapeutic Areas experience is fine as well.

• Candidate will be responsible for the Safety & Risk Management for Developmental and Marketed Products.

Day to Day:

• Perform Safety Analysis for Clinical and post Marketing Data.

• Good Writing Skills.

•  Working close with Physicians and other groups like Clinical & Regulatory in a very busy space.

• Performs primary medical review of serious adverse experience reports and other AE reports of interest to monitor and describes the safety profile of assigned products.

• Taking an active role in the oversight and development of pharmacovigilance and risk management plans with direction/guidance from the CSRM team Assists the CSRM team to prepare responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for Merck products.

• Strategizes with safety team recommending appropriate data to respond to queries and analyze data.

Software: • MS office suite, Veeva(SOP's), RXlogix (PV signals platforms)

Company DescriptionAA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.

AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.Company DescriptionAA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.\r
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AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.

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