Komal Kaur Email & Phone Number

Mississauga, Ontario, Canada

International Pharmacovigilance, Drug safety and Risk Management

Mississauga, Ontario, Canada

Basel Area, Switzerland

Chandigarh, Chandigarh, India

• Expertise in signal detection and in the preparation of aggregate reports relating to signal detection and health authority request, including DSRs, Abbreviated Drug Safety Reports • Analyzing data related to signal detection activities including:• Periodic review of individual case safety report line listings/outputs.• Periodic review of literature.• Trending analysis for product quality defects.• Expertise in using signal detection tools, Empirica and tracking of signals for signal detection activities.• Support review and update of Auto-labelling list following MedDRA version update.• Provide support on safety related queries (e.g.; from regulatory agencies, affiliates and other internal functions).• Case and Context Evaluation for data arising from Signal Detection methods.• Literature review and assessment with special focus on benefit-risk evaluations • Therapeutic areas include Oncology, Transplant,Infections and Infestations, Dermatology, Cardiovascular, Rheumatology, Immunology/Autoimmune Diseases, Metabolism, Hematology, Virology, Psychiatry and CNS, Respiratory Diseases/Conditions• Maintaining a good working knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, aggregate reporting conventions and guidelines, clients procedures and international drug safety regulations including: ICH guidelines on safety and efficacy, GVP Modules, FDA guidelines, CIOMS, New EU PV Legislation, Helath Canada

India

• Data entry of Individual Case Safety Report (ICSR)s 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.• Expertise in MedDRA • Maintaining a good working knowledge of the AE safety profile of assigned products, Reference Safety Information documents, data entry and narrative writing 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 regulatory timelinesQuality Check :• Quality check (QC) of regulatory documents including PBRERs to ensure the accuracy of the data presented RMP• Experienced in updating ETLs when new version of Investigator Brochure and MedDRA is released for generation of summary tables of SADRs for the Developmental Safety Update Report (DSUR) and for Individual Case Safety Report (ICSR) labelling assessments• Quality check Investigator Brochure for consistency of data.

Chandigarh Area, India

⦁ Accurately maintained all patient records including personal & medical information.⦁ Taking Case history and Clinical examinations⦁ Amalgam, GIC and composite restorations⦁ Root canal treatments and post and core⦁ Oral prophylaxis, Extractions, Interpreted x-rays and diagnostic tests