Prithula Kanungoe Email & Phone Number

Cambridge, Ontario, Canada

Healthology and Salus, CanPrev, Natural Factors, Platinum Naturals, Living Alchemy, Naka● Provided quantifiable expertise and attractive discounts to the Customers with regards to Natural Health Supplements resulting in a 20% sales increase and yielding $50,000 profit annually.● Performed precise inventory management through weekly audits, effectively reducing overstock. Additionally, showcased a variety of products and demonstrated new items, emphasizing their value.● Effectively managed the workload and motivated the team to prioritize tasks, resulting in a 25% increase in business value despite staff shortages.● Proactively resolved customer complaints and provided tailored solutions, increasing customer retention by 10% and annual profits by $30,000.● Educated customers about potential side effects and drug interactions, building trust and significantly enhancing their quality of life.

Bengaluru, Karnataka, India

Vision Care and Pharmaceuticals (Contact Lenses and Lens Care Solutions) ● Managed workflow, ensuring equitable case allocation based on priority, saving 15% of missed deadlines and contributed to process improvements, increasing team productivity by 20%.● Facilitated Health Authority Submissions including Medical Device Reports (MDR), Vigilance, and Combo reports by following SOPs and EU regulations ensuring 100% accuracy. ● Conducted timely investigations, analyses, and responses to health authority inquiries (HA), maintaining a 98% resolution rate within mandated timelines.● Monitored I-Track Database for transmission failures, swiftly addressing issues to achieve 100% submission compliance. ● Acted as Subject Matter Expert (SME) on pharmacovigilance global regulations, guidelines, and best practices, enhancing team knowledge and ensuring compliance with a 90% training satisfaction rate.● Supported User Acceptance Testing (UAT) of safety database for reporting configuration and reducing 10% submission failures.

Bengaluru, Karnataka, India

Oncology Division (Serious Adverse Reaction Reports) - Multiple Clients● Generated E2BR3 files and Rich Text File (RTF) in Eudravigilance database for European submissions, streamlining the process by 15%.● Monitored E2B failure transmission, collaborating with teams to rectify issues, ensuring a 98% on-time submission rate and 25% reduction in submission errors.● Identified reasons for delayed Individual Case Safety Report (ICSR) submissions, implementing CAPAs for Compliance and Business Management teams, reducing delays by 30%.● Managed Global submissions mailbox, handling urgent inquiries, and performing daily safety database reconciliation, enhancing response time by 20%.● Provided trainings on submission processes and timelines, offering guidance to new members, resulting in a 95% proficiency rate.

Bangalore

Kolkata

Sanofi (Spontaneous, Non Spontaneous ICSR's, Literature Reports, E2B MLM Reports, Compassionate Patient Supports Programs, Special Case Scenarios ((Drug Exposure During Pregnancy/Mammary Gland) Drug Abuse, Misuse, Overdose, Fatal Cases)), Product Technical Complaints, Legal Case● Processed 20+ ICSR’s daily and written narratives from various sources like Clinical Trial, Spontaneous, Literature Review, Line Listings and Patient Support Program achieving 98% data entry accuracy.● Coded adverse events through MedDRA, generated medical queries and regulatory report forms (MedWatch/CIOMS/E2B) for reportable events lowering the overall case volume by 25%● Conducted active case follow-up, identifying missing information and discrepancies, resulting in a 15% reduction in unresolved cases.● Reviewed SAE/device incident/pregnancy report forms to ensure accurate redaction of patient’s personal information, achieving a 100% accuracy rate.● Performed QC review of data for cases entered by other PV personnel, ensuring 100% case quality● Reviewed Safety Management/Reporting Plans (SMPs or SRP) authored by PV Project Managers, assisting in the development of data collection forms, improving plan accuracy by 25%.S

Bangalore

Multiple Projects Related to Clinical Operations, Pharmacovigilance, Data Managements Audits● Updated EDA (audit database) ensuring accuracy and completeness, resulting in 20% increase audit efficiency and compliance.● Oversaw metric reports through Tibco Spotfire, delivering actionable insights that led to 50% surge in operational efficiencies.● Maintained the electronic quality management system (eQMS), supporting the audit lifecycle, which resulted in process optimization and reduced audit times to 30%.● Monitored deviations and CAPA status to proactively manage and resolve issues, ensuring minimal disruptions and achieving 100% quality performance● Updated Clinical Trial Management Systems for tracking the trial progress and followed up with CRA's.

Bengaluru, Karnataka

Parkinson's Disease● Authored detailed narratives for serious adverse events (SAEs), thoroughly documenting clinical course, medical history, concomitant medications, and laboratory findings.● Produced meticulous narratives on patient deaths, detailing circumstances, autopsy findings, and medical interventions.● Composed narratives on sponsor termination, detailing rationale, safety concerns, efficacy issues, and strategic changes.● Conducted rigorous self-quality control on drafts to ensure accuracy, consistency, and clarity, correcting errors to maintain document integrity.● Maintained and updated document trackers to monitor narrative writing progress, ensuring timely completion and providing regular updates to stakeholders. ● Ensured compliance with SOPs, GCP, and regulatory requirements throughout document creation. Participated in cross-functional meetings to discuss drafts, address queries, and incorporate feedback, fostering collaborative medical writing

Kolkata, West Bengal, India

Homeopathic Formulation (Tablets, Oral Liquids, Oil, Cream Based Formulation, Bulk Herb and Mother Tinctures)● Performed routine testing and analysis of raw materials, in-process materials, and finished products according to SOP● Prepared and maintained accurate records of all testing, results, and observations in compliance with GMP● Assisted in investigations related to non-conforming products, deviations, and out-of-specification results● Conducted physical, chemical, and microbiological testing of products using analytical techniques

Bachelor Of Pharmacy (B.Pharm), Pharmacology,Pharmaceutics, Pharmaceutical Analysis, Pharmacognosy, Pharmaceutical Chemistry, 8.31/9 Gpa

Activities and Societies: Attended seminars related to Drug Development, Poster Presentation on Protein Misfolding, Pharmaceutical.

Postgraduate Degree, Advance Pg Diploma In Clinical Research, A+

Higher Secondary, Maths,Physics,Chemistry,Biology,English,Sociology,Hindi,Bengali, 78%