Proficient in Microsoft Word, Excel and Power Point
Adept at using SHARE, MisAMM, MedRA Dictionary, QUOSA, ARGUS, AWARE
Proficient in using, maintaining and calibrating the following instruments:HPLC, GC, GC/MS, Spectrometer.
Trained in management of Individual Case Safety Reports (ICSRs) which includes: Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities; Registration/initiation of ICSRs into the safety database; Conducting duplicate searches prior to registration and identifying potential duplicates; Managing duplicate cases appropriately; Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing causalities if required and writing company comment if required; Data validation i.e. cross checking against source documentationTrained in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”; Trained in international drug safety regulations including : ICH guidelines on safety and efficacy, Volume 9A , FDA guidelines, CIOMS, New EU PV legislation, Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with required timelines , Trained in handling the ERP (Enterprise Resource Planning) tool
Interacted with appropriate client personnel to resolve issues related to the assigned work; Responded to clients/customers in a timely manner
Received training as a trainer (“Train the Trainer”) for various aspects of PV.Provided trainings to affiliates regarding the software MisAMM, located at different sites via live meetings; Provided trainings to the PV scientists on regulatory data remediation and xEVMPD data capture
Research work experience:
Eight weeks of training at the Human Genomics Centre, Guru Nanak Dev University, Amritsar; Eight weeks of training at the Biotechnology Department, Panjab University, Chandigarh; Four weeks of training at the Microbiology Department, Govt. Medical College, Chandigarh
Successfully undertook the project on “The effect of TV radiations on plant DNA and Chromosome structure” in the year 2009, as a part of Bachelors.
Successfully completed the work on “Cloning and Expression of dapB gene of Acinetobacter baumannii in E.coli cells”, as a part of Masters.
Analytical Research experience:
Recruited to perform research, conduct experiments and perform analytical method development on APIs and FPPs for finding out the purity of a product by using and operating different instruments like HPLC, Titrator, GC, GC/MS with the main focus being on GC. Performed review and validation of thus found analytical data for compliance. Analyzed different samples, APIs and FPPs, to provide information about compounds and quantities of compounds present using GC, GC M/S or Spectroscopy. Interpreted and recorded the data thus found.
Companies Worked For:
Job Titles Held: