Job Location: Bengaluru, Bangalore
Job Title : Drug Safety Associate
Overall Purpose of the Job
Responsible for the processing and evaluation of Serious Adverse Events / Post Marketing
Adverse Events within agreed timeframes and to a high standard of accuracy, in
compliance with client’s, standard operating procedures and global regulatory requirements.
Responsibilities/Authorities
- Major responsibilities: Perform triage including prioritization of cases
- Perform duplicate search in AA
- Create a case (Initial/FU) in AA.
- Update the daily tracking spreadsheet to be exchanged with the Asia CO.
- Enter the mandatory fields in AA
- Upload the Source document in AA
- Receive feedback from the QC associate and make corrections as per feedback (for mentees).
- Make necessary corrections when applicable
- Upload the ESP Source Document Transcription/Translation Quality Control Form in AA following completion of corrections.
- Create followup action item.
- Route the case to Core
- Successfully complete and clear proficiency test in client data base Affiliate.
- Key performance indicators: Ability to learn quickly.
- Number, timeliness and scientific quality of deliverables according to established directives
- Consistent demonstration of company values/behaviours. Ensure that Post Marketing Adverse Events are evaluated accurately and within the required timeframes to meet regulatory requirements
Requirements
• A Bachelor’s degree in a science-related field, pharmacy, nursing, registered dental, or equivalent; HCP qualification required.
• Preferred, but not required: A minimum of 1 year clinical experience, or its equivalent, in Pharmacovigilance, hospital or pharmacy; familiarity with clinical assessment an advantage
Benefits
Submit CV To All Data Science Job Consultants Across India For Free
