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Job Details:
Position Name : Medical Reviewer
Location: Bengaluru, Karnataka
Job ID : 642803474d579303
Description : Job Description
We are currently seeking a Medical Reviewer to assist in activities requiring clinical or post-marketing pharmacovigilance service lines. Within the role you will:
Conduct the review and assessment of individual case safety reports from clinical trials, spontaneous and solicited reports
Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within the assigned therapeutic team and across all products and sites as necessary
Perform triage of cases and determine seriousness and relatedness across products as assigned
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling, review narrative.
Acquire and maintain current knowledge of the product portfolio and safety profiles for products across therapeutic areas
Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
Conduct assessment of litigation cases across products as assigned
Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues
Prepare and review periodic aggregate safety reports
Support the preparation and maintenance of safety sections of the Company Core Data Sheet
Lead/support PDS post-marketing safety study activities
Carry out signal detection activities and evaluation
Follow up on reconciliation of discrepancies.
Perform literature review activities when trained and assigned.
Participation in local or global project teams, including on-time delivery of assigned responsibilities
Oversee, improve and contribute to procedures and performance
Collaborate in the development, review and initiation of SOPs
Interact with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects
Identify, document and appropriately resolve out-of-scope work as directed by senior management
Maintain working knowledge of GCPs and regulatory requirements relating to clinical and PV teams to assure compliance with regulatory standards
Mentor other staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, support Senior Management’s leadership of both the department and the company
Read and acknowledge all necessary standard operating procedures as required.
Execute administrative operational tasks as required
Provide oversight on operational activities and sound understanding on project plans/documents.
Participate in team meetings and provide regular feedback to the management on operational metrics and other challenges/issues.
Desirable Skills and Experience
Sound knowledge of the PV domain and working experience in life cycle safety services
Good knowledge of Clinical and PV Drug Safety procedures and regulations
Excellent computer skills and knowledge of MS Office including Word, Excel, and PowerPoint
Excellent organizational and time management skills
Bangalore, India
MBBS or MD Pharmacology
Associate
Pharmacovigilance and Safety
Full Time
31 Jan 2022
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