Pharmacovigilance Services Sr Analyst

Skill required: Pharmacovigilance Services - Safety Writing
Designation: Pharmacovigilance Services Sr Analyst
Qualifications:Bachelor of Pharmacy/Master of Pharmacy/BSc. Nursing
Years of Experience:5 to 8 years
Language - Ability:English(Domestic) - Expert
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? Prepare and review RMP/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. Perform scheduling of reports, and author, peer review, publishing and tracking activities of assigned reports. Requesting for inputs, literature screening for assigned reports. 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. Manage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for completed/interim clinical study reports.
What are we looking for? •
Roles and Responsibilities: •In this role you are required to do analysis and solving of increasingly complex problems • Your day to day interactions are with peers within Accenture • You are likely to have some interaction with clients and/or Accenture management • You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments • Decisions that are made by you impact your own work and may impact the work of others • In this role you would be an individual contributor and/or oversee a small work effort and/or team • Please note that this role may require you to work in rotational shifts

Bachelor of Pharmacy,Master of Pharmacy,BSc. Nursing