Job Description
Skill Required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Specialist
Qualifications: Any Graduation
Years of Experience: 8 to 9 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 over 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 You Will Do
You will be aligned with our Life Sciences R&D vertical, which spans the entire life sciences enterprise—from research laboratories and clinical trials support to regulatory services, pharmacovigilance, and patient services solutions. In this role, you will assist leading biopharma companies in improving outcomes by integrating scientific expertise with unique patient insights. Your responsibilities will include managing the Affiliate Mailbox, reconciling reports, and performing follow-ups for both Serious and Non-serious cases. You will also create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for Individual Case Safety Reports (ICSRs) in the safety database according to client guidelines and global regulatory requirements.
What We Are 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 or closely related areas, or 2 years in medical writing or experience in aggregate reports.
Roles and Responsibilities
Prepare and review Periodic Safety Update Reports (PSURs) as per Client Standard Operating Procedures (SOPs) and Work Instructions.
Identify contributors from the contact list; if unavailable, reach out to the Brand Safety Leader (BSL).
Send out Kick-off Meeting (KOM) invites to contributors, including agendas, PSUR preparation guides, previous PSURs, Core Data Sheets (CDSs), and any relevant assessment reports from health authorities.
Coordinate with Client Drug Regulatory Affairs for necessary information such as brand names, country of submission, and registration procedures.
Collaborate with the Client Pharmacovigilance Data Management (PVDM) team to confirm Argus drug codes with Client Safety physicians prior to KOM.
Ensure confirmation of drug codes and requirements for integrated medical safety data during KOM.
Liaise with relevant stakeholders for necessary inputs for PSUR preparation.
Notify the processing team to manage cases as per the PSUR schedule.
Coordinate the data cleaning process before final listing generation.
Schedule meetings with Client safety physicians to resolve report-related queries.
Act as lead author to prepare submission-ready draft reports and perform peer reviews, providing feedback via a defect tracker.
Ensure completeness and accuracy of source documentation for PSUR/AR.
Facilitate reviews by Novartis stakeholders, including QC and QPPV reviews.
Address all comments from Client stakeholders, ensuring consistency in formatting and compliance with Client Style before submission.
Escalate any delayed inputs on time.
Archive all PSUR-related information in dedicated folders on Client Shared Drives.
Upload the final Periodic Benefit-Risk Evaluation Report (PBRER) to the Document Management System (CREDI) for publishing and ensure TASL approval.
Update the PSUR tracker in I-drive for all key performance indicators (KPIs).
Andra Pradesh :
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