Quality Assurance Medical

SUMMARY:

• * years of Pharmacovigilance experience as Drug Safety Associate for both clinical and post marketing drugs in the pharmaceutical industry

• Maintain a high level of vigilance to clearly identify cases that require high priority processing to prompt reporting of serious adverse events in accordance with company SOPs, FDA, ICH and global regulations

• Excellent in handling calls from HCPs, investigational sites in order to distribute accurate notes to the team

• Experience in daily activities including triaging cases, accurately encoding them into the safety database, writing an accurate and concise narrative, reviewing source documents, medical records and literature documents

• Correctly assessing case reportability, as well as correctly identifying duplicate cases and taking the appropriate action to request case inactivation or a case merge

• Proficient in data entry and excellent knowledge of ARGUS and ARISg safety databases

• Excellent command on medical terminology and expertise in the utilization of MedDRA for coding adverse events and drug information in accordance with WHO-DD

• Experience in defining and appraising patient medical history, critical event information from reporting sources including follow-up information from the investigational sites to complete a good quality case narrative in compliance with company standard operating procedures as applicable

• Well-coordinated with the in-house physician, nurses for clarification and effectively communicated with the hospital call centers for specific drug related information

• Excellent knowledge of IND safety reports and PSURs reporting guidelines

• Submission of product complaints and technical complaints to product monitoring and Quality Assurance team respectively

• Excellent written, oral, communication and presentation skills

• Team Player, Consistent, committed to work and have the desire to take responsibilities and fulfill them effectively

• Quick learner, self-motivation and efficient management and leadership qualities