Safety Medical Reviewer
Safety Medical Reviewer
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Safety Medical Reviewer for our client in Peapack, NJ.
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- The Safety Medical Reviewer will perform the medical assessment activities related to drug safety pharmacovigilance for the assigned therapeutic area(s).
- The Safety Medical Reviewer proactively evaluates safety information from individual cases and cumulative data, identifies and analyzes potential signals, and communicates data-driven conclusions to internal and external stakeholders.
- Perform single case medical assessment, including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions
- Maintain the timely submission of expedited reports
- Support the achievement of the Therapeutic Areas case processing performance timelines
- Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unbinding process (as appropriate), and make the report available for distribution
- Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems
- Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders
- Partner with Safety Surveillance and Risk Management and with other Worldwide Safety and Regulatory functional groups to monitor the safety profile of assigned products
- Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate
- Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness/listedness/labeledness, causality, and data reconciliation
- As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries
- Work with the Therapeutic Area Head and Medical Review Head to proactively and effectively communicate product safety issues and proposed solutions to PSSR management and to the Office of the EU Qualified Person
- Provide timely review of and input to documents, including labeling, protocols, Investigator Brochure, and licensing agreements
- Provide timely input into product related milestones
- Provide medical input, review and analysis of Periodic Safety Update Reports, Expert Statements, Risk Management Plans, and other aggregate reports; where appropriate, draft components of these reports. Ensure accurate, relevant, and meaningful ICSR data and insights
- Provide medical advice and insights to Therapeutic Area colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports
- Support PSSR Quality Assurance activities, addressing observations related to medical assessment, as appropriate. Ensure consistency and quality of the medical assessment process
- Provide drug safety support when appropriate to product acquisitions, recalls, and legal issues
- Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed
- Proactively communicate with and engage Therapeutic Area colleagues and key stakeholders (e.g., Clinical Development Teams, Regulatory Affairs, Licensing, Manufacturing, and Marketing) to support business objectives and to discuss and resolve safety issues
- Medical Degree from an accredited institution, with relevant experience
- Experience in pharmacovigilance, clinical research or related field. Pharmaceutical industry experience preferred
- Demonstrated computer literacy, with proficiency in the use and management of safety databases, including the Client Global Safety Database, Argus Safety, and MS Window, Excel, Word and Outlook
- Ability to achieve personal objectives while meeting departmental standards of performance
- Fluency in oral and written English; knowledge of addition
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.