Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Sr Analyst
Qualifications:Any Graduation
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 world’s 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? Aggregate Reporting 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? Educational requirement: B.Pharm / M.Pharm / PhD / BDS /BHMS /BAMS/ Masters in Life Sciences. Work experience requirement: 4 to 5 years of experience in drug safety / Development or closely related areas of responsibility or 2 years in medical writing or working experience in aggregate reports.
Roles and Responsibilities: Responsibilities/Authorities • Prepare and review PSURs as per the Client’s (CLIENT) Standard Operating Procedures and Work Instructions. • Identify contributors based on the contact list if the same is not available, contact Brand Safety Leader (BSL) • Send the kick-off meeting (KOM) invite to all the contributors along with agenda, PSUR preparation guide, Previous PSUR, Core Data Sheets (CDSs) or reference safety information, previous PSUR assessment report from HA (if any) and dial-in details. • Liaise with CLIENT Drug Regulatory Affairs team and request brand names generic names, country of submission, registration procedure, HA PSUR assessment report (if any), and CDS for reference. • Liaise with CLIENT Pharmacovigilance Data Management (PVDM) team to provide the Argus drug codes and get it confirmed by CLIENT Safety physicians before KOM. • Ensure the confirmation of drug codes is addressed during the KOM. Ensure the confirmation on the requirement for POP information/Integrated medical safety data from BSL during the KOM. • Liaise with relevant stakeholders for the inputs required for the PSUR. • Notify the processing team to process relevant cases as per the PSUR schedule • Coordinate data cleaning process (missing data clearance and send request for stop/ resume book in of cases) prior to final listings generation. • Schedule meetings with CLIENT safety physicians to resolve report related queries. Perform activities as lead author and prepare submission ready draft report. • Perform peer review of draft reports and provide feedback with the duly filled defect tracker. • Capture quality data for metrics reporting. • Completeness and accuracy of source documentation provided by CLIENT for PSUR/AR to be ensured. • Facilitate Client stakeholders review including QC & QPPV review • Shall address all the comments received from all the CLIENT stakeholders including QC reviewer • Shall use NovStyle and ensure consistency in formatting before submission Ensure the consistency, • On-time escalation of any delayed inputs • Archival of all the PSUR related information in dedicated folders on Client Shared Drives • Upload final PBRER in Document management system (CREDI) for publishing and ensure that the TASL approves the PBRER. • Email PSUR Mail-box for initiating publishing of the final report in CREDI as soon as approved by TASL in CREDI, • Update PSUR tracker in I-drive for all KPIs