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MEDICAL REVIEWER

Zenith LifeScience
South Plainfield, NJ

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Job Details

Full-time
$100,000 - $120,000 a year

Qualifications

Optimizing workflow processes
Regulatory inspections
Doctor of Medicine
Microsoft Excel
Team leadership
English
ICH guidelines
Continuous improvement
Pharmaceutical company experience
Clinical program data analysis
Vendor communication
Communication with regulatory authorities for clinical trials
Clinical research inspection readiness
Productivity software
Clinical quality assurance standards
Clinical data analysis
Research findings presentation
Project leadership
Pharmaceutical research experience

Full Job Description

Department: PV (Clinical Operations)

Responsibilities:

Reviews the Adverse event case narrative, coding, product/Indication, labeling in accordance with the respective reference safety documents, causality and Medical history for medical completeness, accuracy, and overall medical content.
Analyze medical data to investigate causes and treatment of toxicity, pathogens, or chronic diseases and adverse event reaction caused due to drugs given for medication.
To Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents
Review a Line Listing of cases and evaluates the coding and labelling and confirm the events are evaluated correctly.
Manage review of cases according to internal timelines
In conjunction with pharmacovigilance scientists and physicians contribute to writing and maintaining Risk Management Plans.
Contribute to solving reconciliation medical coding issues/discrepancies
Review and update generated follow-up letters for the prescribers and investigators as appropriate.
Responsible for Company sponsored clinical trials, confirms that a case is a SUSAR case or an otherwise expeditable report which requires unblinding
Responsible to support in preparing aggregate safety data reviews for pre-and post-marketing ASRs including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development safety Update Reports (DSURs), IND annual reports, and other Ad-hoc reports
Liaise with marketing team(s) to evaluate safety impact and provide input into program design (e.g., social media, market research, patient support programs).
Assist in writing and/or reviewing of monthly safety signal reports

Skills Require:

Demonstrated qualities of competency, accountability, initiative, and leadership
Experience in process improvement initiatives
Extensive knowledge of US, ICH and EU PV and GCP regulations
Excellent strategic decision-making and analytical skills
Computer skills including proficiency in use of Microsoft Word, Excel & PowerPoint
Strong leadership skills with excellent track record
Strong verbal, writing and organizational skills, including good command of English
Experience with Regulatory Authority Inspections (PV and GCP)
Experience working with vendors

Educational and/or experience requirements:

A physician (MD or equivalent) with 3 +years pharmaceutical experience preferably performing Medical Review. Ability to critically evaluate safety data from multiple sources (clinical trials, literature, etc.), assesses clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communication is required.

Job Type: Full-time

Salary: $100,000.00 to $120,000.00 /year

Please send profile at [email protected] for direct consideration or question.

Posted on 06/01/2022

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