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Post : Senior Drug Safety Associate
Job Description :
• Implement Quality Checks steps on all its processes and procedures during the execution of the Services in order to provide quality Services to Client.
• Review overall quality of the ICSR case, including the completeness of the information, accuracy of the data entered, and appropriateness of the causality assessment.
• focus on the locked cases from the previous daily, by taking random samples for Quality review. All the sampled cases should be reviewed within the agreed timelines.
• Document the detected errors and perform root cause analysis.
• communicate observations (potential errors) identified during quality check of the case to the individual involved in processing of case via email.
• To mentor and train new hires or other associates.
• Open to get trained and move across roles based on business requirement.
• Supports audits and inspections, develop corrective/preventive action plans
• Authoring of process documents
• Escalate issues or tasks outside the normal scope of work.
Candidate Profile
• 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 2 years of experience in Pharmacovigilance required; 3- 6 months of experience with NVS Process, conventions and products preferred.
• Thorough knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug
• Good Communication Skills
• Analytical Ability
• Technology skills: experience with MS office, knowledge of safety database
• Automation technology as applicable for the role
• Strong English Language proficiency (Reading and Writing)
• Good English Language proficiency (Listening and Speaking)
Additional Information
Experience : 7 to 11 years
Qualification : M.Pharm, B.Pharm, B.Sc
Location : Bengaluru
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Pharmacovigilance & Drug Safety Surveillance
End Date : 20th June, 2023
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