Bhawna Vaish

I am pharmacology postgraduate with a work experience of 4 years in teaching and 2 years in pharmacovigilance. Currently I am working with Parexel Internation, Chandigarh as a drug safety associate 2 in ICSR. I process ICSR case, coding MedDRA, handling client query, quality review of the case. I am well versed with computing skills and a good communicator, adaptive, flexible and team worker with positive attitude.

• Trained in management of ICSRs of all case types (spontaneous, clinical studies and solicited programs) which includes: triage of ICSRs, initiation/registration of ICSRs into the safety database, conducting duplicate searches prior to registration and identifying potential duplicates, managing duplicate couples/cases appropriately, coding of ICSRs in the safety database, including determining the expectedness of adverse events against various labelling documents (such as Summary of Product Characteristics (SPC), Core Data Sheet (CDS), Investigator's Brochure (IB)), writing case summaries, assessing causalities if required and writing company comment if required, trained in Medical Dictionary for Regulatory Activity (MedDRA) coding, maintaining a good working knowledge of Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations, maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with international and regulatory timelines for adverse event reporting, trained in handling the Enterprise Resource Planning systems (ERP)
• Query management: Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with clients policies, Responding to clients/customers in a timely manner, requesting additional information as needed from the appropriate sender (affiliate sites, licensee partner, investigators, etc.),as required and identifying areasof concern withinthe team and raises the issues with the Team Lead
• Teaching: assistant professor of pharmacovigilance. 

4 years experience in teaching a pharmacology subject and 2 years of experience in Pharmacovigilance work