Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance

Designation: Pharmacovigilance Services Analyst

Qualifications:Bachelor of Pharmacy/Master of Pharmacy/BSc. Nursing

Years of Experience:1 to 3 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 784,000 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 PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents on the project. Perform scheduling of reports, and author, peer review, publishing and tracking activities of assigned reports. Perform request for inputs activity for the reports (based on the RFI [request for information] and as per the applicable process and SOPs). Send the case closure request and request for Line Listings/Summary Tabulations, as applicable. Initiate, organize, and lead the strategy meeting for evaluation of safety topic/request. Prepare meeting minutes and distribute final minutes with all invitees. Pharmacovigilance Operations involve monitoring and assessing the safety of pharmaceutical products. This includes detecting, evaluating, and preventing adverse effects or any other drug-related problems. The goal is to ensure that medications are safe for patients and to comply with regulatory requirements. These operations involve collecting and analyzing data from clinical trials, healthcare providers, and patients. Effective pharmacovigilance is crucial for protecting public health and maintaining trust in medical products. 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 Prepare and review PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents on the project. Prepare and review PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents on the project.

Roles and Responsibilities:

In this role you are required to do analysis and solving of lower-complexity problems
Your day to day interaction is with peers within Accenture before updating supervisors
In this role you may have limited exposure with clients and/or Accenture management
You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments
The decisions you make impact your own work and may impact the work of others
You will be an individual contributor as a part of a team, with a focused scope of work
Please note that this role may require you to work in rotational shifts