Neha Kushnoor

Motivated jovial person who met the objective set at academics and at work till now. Demonstrated strong work ethic, critical thinking and creative abilities. Seeking to step-up for excellence in chosen path for growth.

Vendor Management, Project Safety and risk management, checking on productivity, timelines, quality, queries and improvising process whenever required. Training new joiners and guiding on vendor management project. Involved in billing, TAT verification. Previously worked on pharma and consumer products includes SUSAR cases in immunological products, clinical trials, non-serious, serious cases (which includes company device malfunctions), evhuman, literature cases and worked on Consumer products (specifically on cosmetic products) with other vendor as a part of BCP. Also worked on oncology, psychiatry and legal (compensation claims area). Apart from managing goals, learnt and managed workflow management, team's data analysis and was involved in initiating fun activities. Clinical trial SME, Implicated ICH-GCP, FDA and other regulatory bodies rules and timelines, into type of cases actioned to meet the compliance of each step. Hardworking and passionate job seeker with strong organizational skills eager to secure entry-level [Job Title] position. Ready to help team achieve company goals. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

• Processed Lifecycle Safety data according to applicable regulations, guidelines, standard operating procedures (SOPs) and project requirements related in multivigilance (Pharmacovigilance and Cosmetovigilance) meeting with all regulatory bodies' rules and timelines before deadlines.
• Clinical trial SME at center level and working on all associated work.
• Positioned as line manager's back up for work allocation and related activities for 3 years under direct training by managers, versed with management tools for both in Pharma and Consumer
• Performed Quality check metrics in multiple projects includes cases e.g: serious cases, EVHUMAN, literature cases and SUSAR case check identification, processing, notification to pharmacovigilance physician and well versed in CT case processing, which was shared in regular team huddles with the help of excel and graphs to track trends on low quality and addressed on how it could be arrested to improvise quality of the cases to meet standards of 100%.
• Database experience: Sceptre, Aris-g, Argus. Labelling assessment, New update execution in team check.
• Managing TAT (turnaround time) in case allocation to team which is leading to closure of cases at each step well advance in timelines (to adhere processing timelines as per internal and external), by tracking all case, with the utilization of tools for cases present in workflow to manage departmental workload, which in turn gravitates the volume down at faster rate and boost the productivity and reduction in missing timelines at significant level.
• Handled Global Medical Safety (GMS) and regional queries across teams.
• Was Part of SME Panel for training/mentoring new hires on complete working of the Safety database.
• Performed Quality Review of Adverse Event Reports (ICSRs) in Global Safety Database which included verifying MedDRA coding, Product coding using CPD and WHO, verifying safety narratives according to guidelines, SOPs and to check whether the process adhering to regulatory protocols.
• Ensure that all safety reports received from any source (clinical trials and post-marketing), for assigned products and/or studies, are appropriately triaged, processed, discussed with internal pharmacovigilance physician and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies, as per PVA and regulatory timelines.
• Worked in tracing productivity, quality, errors data analysis for team and demonstrated with writing skills to management, which decrease errors.
• Skills to create working environment very light, jovial and friendly, where one can work with ease and at comfort, for which was selected to be a part of buddy program to guide new joiners to adjust in the new circumstance.
• Ensured deviation memos are being shared across teams, so no new errors would be accidentally committed by other team members, by coordinating with compliance team members.

• Myocardial Ischemia Reperfusion Injury Pathogenesis and Prevention, International Journal of Research in Pharmaceutical and Biomedical Sciences Vol. 3(2) Apr- Jun2012)
• An Anxiolytic Effect of Myristica Fragrance, International Journal of Phytotherapy Research. Vol. 3. Issue 1, 2013
• Effect of meditation and hypnosis on stress levels of railway employees (coauthor), Biosciences International. Vol 2, No1 (2013)
• A study on Antihypertensive Drug Utilization Pattern in Presence of Diabetes Mellitus, Jun 2014

• Date of Birth: 04/16/91
• Gender: Female
• Marital Status: Unmarried

• 16TH Annual National Convention of APTI-2011 held on 07-Oct-2011 at ISF College of Pharmacy, Moga, Punjab (India)
• 5th Annual Karnataka Science and Technology Academy (KSTA) Conference-2012. Bangalore, Karnataka
• 46th Annual Conference of Indian Pharmacological Society at NIMHANS convention Centre, Bangalore, Karnataka
• Drug Prescription: Current Scenario held on 12-Dec-2014 at KSHEMA, Mangalore, Karnataka

• Certified Investment Banking, IIT G - 01-Mar-2023 to 01-Oct-2023