Pharmacovigilance Services Specialist

Job Description

Skill required: Pharmacovigilance Services - Safety Writing Designation: Pharmacovigilance Services Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 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 Prepare and review PSURs as per the Clients Standard Operating Procedures and Work Instructions. What are we looking for Ability to establish strong client relationship Roles and Responsibilities: Prepare and review PSURs as per the Clients Standard Operating Procedures and Work Instructions.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 relevant stakeholders for the inputs required for the PSUR.Notify the processing team to process relevant cases as per the PSUR scheduleCoordinate 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 reviewShall address all the comments received from all the CLIENT stakeholders including QC reviewerOn-time escalation of any delayed inputsArchival of all the PSUR related information in dedicated folders on Client Shared Drives Qualification Bachelor of Pharmacy