Drug Safety Specialist - Kolkata, India - The Hird

Description

• Role – Drug Safety Physician.
• Designation – Sr. Executive.
• Location – Pune.
• Qualification – MBBS/MD (Pharmacology).
• Experience – 2 to 7 Years (ICSR)
• Mode - Work from Office. (Kolkata)
• Notice Period – Immediate joiners preferred.
• CTC- Upto 25 LPA

Position Purpose: To Analyze, Review and Interpret Safety data.

Primary Responsibilities:

• To Perform medical review of cases according to Wipro and client specific SOPs and conventions and guidelines in safety database.
• Provides technical and medical expertise in medical assessments of causality of cases as necessary, including the assessment of quality within the process.
• Perform quality review of completed or locked cases in safety database as required.
• Writing of medical assessment comment in safety database
• Identify process improvement opportunities and drives changes.
• Contribution to safety and Pharmacovigilance training programs, development of Standard Operating Procedures and Other guidance documents.
• Demonstrate Knowledge and ensure compliance with current and applicable global Pharmacovigilance regulations and guidelines.
• Review the Adverse Events case Narrative, coding, Product/Indication, labelling in accordance with the respective reference safety documents, causality and medical history for medical completeness, accuracy and overall medical content.
• To Review and Provide PV Therapeutic area input for development of protocols, IBs, SAPs documents, if required.
• Contribute to solving reconciliations medical coding issues or discrepancies.
• Identifies, communicates, and effectively manages potential safety issues.
• Perform corrections, route cause and corrective & presentive actions if required
• Perform other duties as assigned to support PV activities.

Additional Responsibilities:

• Document and track all observations and recommendations in quality feedback tracking tool.
• Provide appropriate feedback to the Team as and when needed.
• Support revision/creation of workflow/process documents to optimize and/or improve quality and compliance.
• Participate in inspections and audits by providing the requested information.
• Promotion of awareness of procedural and quality requirements within the team.
• Assistance in preparation or implementation of corrective/preventative actions relating to case processing.

Technical Competencies:

• Knowledge of applicable regulations and guidelines for Pharmacovigilance.
• Excellent understanding of medical terminology and familiarity with principles of clinical assessment of adverse events in the context of an international pharmaceutical industry.
• Ability to independently resolve routine problems related to core case processing and surface issues constructively.
• Demonstrated computer literacy, particularly in the use and management of relational databases.
• Ability to manage one's own productivity, time management, quality, and compliance in order to achieve acceptable results within given timelines.
• Ability to achieve personal objectives while meeting departmental standards of performance.
• Ability to work under supervision in a matrix organization.
• Ensure training and understanding on case processing SOPs/guidelines/tools.
• Prioritize cases as appropriate or as directed by Client.
• Excellent oral and written communication skills with fluency in spoken and written English.

Qualification: MBBS or MBBS/MD degree from recognized Indian Medical College or Foreign Medical Graduates Exam (FMGE) Certified

Work Experience: 2 years of experience as Medical Reviewer or minimal 1 year of experience in aggregate analysis.