It is the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions.
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Job Description :
• Priorities case processing activities for ICSRs in accordance with project guidelines, Regulatory due date and TAT SLAs and KPIs.
• Processing and evaluation of Individual Case Safety Reports
• Consistent data entry and processing from source documents, adhering to timelines and quality.
• Confirm accurate and consistent coding of medical history, drugs and adverse event terms.
• Assess adverse event reports for seriousness, causality and expectedness as per applicable labeling, consulting the Medical Reviewer whenever needed.
• Alert the Medical Reviewer of potential safety issues and assist the Medical Reviewer in monitoring the safety profile of product as appropriate.
• Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional/missing information as stated in the relevant Project SOP.
• Archive all communications/clarifications related to the Case in the Global Safety Database.
• Initiate and handle case deletions/ nullification as appropriate.
• To participate in audits or inspections.
• Open to get trained and moved across roles based on business requirement.
• Training and mentoring to new associates.
• Authoring of process documents.
BSc/ Bachelor of Pharmacy/ Master of Pharmacy
• Ability to work well in a team
• Adaptable and flexible
• Agility for quick learning
• Commitment to quality
• Detail orientation Educational and Experience Requirements:
• Minimum of Bachelor’s degree in Health Sciences; Bachelor’s Degree in Life Science with relevant Pharmacovigilance experience
• A minimum of 1 years’ experience in pharmaceutical or clinical research preferred.
• Knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug
• Good medical writing skills
• Good Communication Skills
• Analytical Ability
• Strong English Language proficiency
Experience : 1-3 years
Qualification : BSc/Bachelor of Pharmacy/Master of Pharmacy
Location : Bengaluru
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Pharmacovigilance & Drug Safety Surveillance
End Date : 15th July, 2023