Dr Rajasekhar Reddy B

• Perform medical review of non-serious and serious ICSRs with emphasis on seriousness, expectedness, causality & narrative, etc. without missing on quality & compliance.
• Experience in medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
• Support 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 labeling and review narrative.
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
• Involve in process improvement activities such as implementation of quality control process.
• Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
• Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
• Maintain Pharmacovigilance expertise and understanding of international safety regulations and guidelines.
• Responsible for completing the medical review activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
• Provide timely feedback to case processors on the errors/discrepancies noted.
• Assist in training/mentoring of other case processing/medical review personnel as necessitated.
• Participate in organizational activities to meet objectives suitable for the role/area of expertise.

· Handling emergency cases & OPD patients.

· Performed minor OT procedures & Assisted the senior doctor in major surgeries.

· Trained in Basic life support & Advanced Trauma Life Support.

· ICU management.

· Periodically meeting the patients and observing their improvements and making reports.

· Carefully analyses test results to diagnose illness and prescribe medication accordingly.

· Excellent patient and family communicator, decision making under pressure.

· Caring and empathetic, expert in handling equipment and machinery.