Pharmacovigilance Services Senior Analyst

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Senior Analyst
Qualifications:Bachelor of Pharmacy,Master of Pharmacy,Master Of Physiotherapy
Years of Experience:5 to 8 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do? 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 business rules, standard operating procedures and global regulatory requirements. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
What are we looking for? Bachelors Degree in life sciences 0-1 year of Pharmacovigilance or relevant Clinical Experience English (Read/Write).
Roles and Responsibilities: Major responsibilities: Perform triage including prioritization of cases. Perform duplicate search in Argus A?liate (AA). Create a case (Initial/FU) in AA. Update the information in Optima and or daily tracking spreadsheet to be exchanged with the CO. Enter the mandatory ?elds in AA Upload the Source document in AA Receive feedback from the QR associate and make corrections as per feedback. Make necessary corrections when applicable. Create follow-up action item. Route the case to Argus Core.