Prerna Chhatwal Email and Phone Number

 Lead quality reviewer. Ensuring team processes ICSR’s with high quality standards as per applicable, guidelines, standard operating procedures (SOPs) and project requirements.  Principal trainer for the new experienced and amateur team members. Workflow management to ensure all the ICSR’s are processed within stipulated timelines.

 Case triaging and reviewing safety data from various sources within stipulated timelines and quality standards. Perform data entry and quality check of valid individual case safety reports into ARISg safety database using MedDRA dictionary. Scripting descriptive case narratives, generating queries pertinent to the case, ensuring ICSRs are processed within assigned deadlines according to applicable regulations, guidelines, standard operating procedures (SOPs) and project requirements.  Assisting in various project management activities including follow up requests, CIOMS and line-listing generation and tracker(s) updation.  Engaged in working on European Drug Safety database: EVMPD, manual recoding of terms, EVPRM creation or any other related activity as per the project requirement.

Managing case processing by case triaging and data entry and assuring Quality check (QC) of cases for submission to Regulatory Authorities in EEA in ARGUS Database.MedDRA (Medical Dictionary for Regulatory Activities) code for each adverse event and accuracy of product label assessments for each adverse event.Preparation and review of Periodic Safety Update Reports for active moieties on cyclical, renewal and adhoc basis as per EU and DCGI requirements.Preparation of detailed description of pharmacovigilance system for regulatory submissions.

Worked on a qualitative research project "Does Knowledge, attitude, and behaviour of pharmacists and pharmacy staff affect the implementation of community pharmacy led chlamydia screening test programme." This was a placement based dissertation project which involves 6 weeks of placement in the host organization. The project is based on a descriptive cross-sectional design which will use a convenience sample size of 8 pharmacists and pharmacy staff in a community pharmacy offering chlamydia screening. Data collection methods were questionnaire and in-depth interviews.Systematic Reviews- Has carried out a mini systematic review and meta-analysis on the "Effects of the drug Prucalopride on people suffering from chronic constipation" using the Rev Man 5.Research Proposal- A research proposal on the topic ''Do medical practitioners in government hospitals in developing countries adhere with RNTCP guidelines for rational prescribing of anti -tuberculosis (anti- tubercular) drugs'' was successfully prepared.

the QA & QC department. The main domain of focus was review of failures, rejections, market complaints, deviations, non-compliances, product stability and various corrective & preventive actions planning adhering the international c-GMP regulations.

Pharmaceutical drug profile of antifungal drug-Fluconazole Presented a seminar on the pharmaceutical drug profile of antifungal drug Fluconazole in the Analytical Department New Drug Delivery Research (ADNDDR), Ranbaxy Pharmaceuticals.Mass, NMR , IR ,UV spectroscopy were carried out for the API along with its water content and hydrogen ion concentration using Karl Fisher Titre meter and pH - meter.Valid searching of literature was enacted on major data bases.