Jitesh Karthan

As Deputy General Manager for PV operations involved in building end to end PV processes to hematinic giant by implementing Veeva Safety, Veeva Docs, Veeva RIM suites for managing ICSR, PADER, Signal and regulatory submissions. Other roles include

• PV operations management
• People management
• Resource management, staffing

Took responsibilities of ICSR process lead (people and operations management as second line manager) and acted as a subject matter expert for safety domain (drugs, cosmetics, medical devices and nutraceuticals).

• Managing 15 resources from case intake, case processing, quality review and submissions team.
• Visualizing and reviewing quality, productivity metrics.
• Driving compliance targets (KPIs, SLAs). Ensuring strict adherence to SLAs and KPIs
• Assisting, guiding and mentoring team members on database usage, case processing and reporting.
• Managing safety related requests from partners and distributors and ensuring queries are answered promptly.
• Taking part in management operating systems (steering committee meetings).
• Managing attrition's, capacity utilization.
• Performing career counseling to resources.
• As a globally certified trainer conducted pre-process trainings to 150+ new joiners onboarded to Accenture in PV services.
• As a lead helped in bringing new line of business Affiliate activities, local submissions, reconciliation processes, Eudravigilance screening and literature screening.
• Managed two database migrations from ARISg to ARGUS 8.1.3.

Initiatives During Pandemic:

• Hiring assessments were built specific to ICSR, AR roles. Assessment modules were then made online to hire right resources during pandemic.
• Comprehensive training modules for drugs, cosmetics, medical devices were developed. These were then integrated to e-learning methodologies (first of its kind in PV industry).
• Involved in building procedures (SOPs/SWIs) for end-to-end PV processes. This was helpful in demonstrating organizational capabilities during RFPs.

Post successful transition, product portfolios were expanded to medicinal devices (Type I, II, III) and nutraceuticals.

• Stated managing 6 resources in case intake team
• Managed end to end case intake operations for spontaneous, literature, solicited (post marketing and clinical trials), health authority cases.
• Became a part of training and capability development team. Recognized as Globally certified trainer for Accenture and a European pharmaceutical giant.
• As a lean, six-sigma certified resource performed entitlement studies, time and motion analysis for gaining efficiency in case intake process.
• Helped in computer system validation, installation, operational and performance qualification of natural language processing, robotic and AI enabled tools built by Accenture.
• Worked in deep learning activities of PV first engine (now known as Intient) (world's first AI enabled engine for patient safety).

Worked in therapeutic areas of dermatology and cosmetology. Product portfolio included anti acne, anti rosacea drugs and cosmetic products. Worked on ARIS 6, ARIS 7.

• Helped in transition and stabilization of new Pharmacovigilance business for a European Pharmaceutical company.
• Managing case intake backlog, case processing inventory during transition
• Owner of quality control process (In-line quality and post approval ICSR quality, line listing review quality)
• Helped aggregate reporting team by being a subject matter expert in extracting SAP BO, BI reports
• As a technology master (RPA) for Accenture, drafted rules, scripts during development of robots for patient safety.
• Helped in development of worlds first robot for patient safety for 2 pharmaceutical giants

Worked in therapeutic areas of immunobiology (Monoclonal antibodies to treat auto-immune disorders), neurology (anti-epileptic and anti-Parkinson drugs) and anti-histaminic drugs. Work profile included

• In-line Quality control of serious ICSRs.
• Identifying errors in ICSRs. Requesting for an appropriate root cause. Performing RCAs using 5Y, fishbone methodologies.
• Implementing and documenting corrective and preventive actions taken.
• Preparation of weekly, monthly error trend reports.
• Driving refreshers and trainings across teams to build quality.

Work profile included

• In-line Quality control of non-serious cases processed by case processing team
• Validation of medical terminologies using MedDRA dictionary
• Expectedness assessment of adverse events against (IB, CCDS, USPI, JPI, SMPC, CPM)
• Company causality assessment using WHO-UMC scale
• Evaluation of case narrative and company comments
• Approval and Distribution of non-reportable cases

Worked in therapeutic areas of immunology (vaccines, biologics), contraceptive implants and oral women health products. Worked on Oracle Argus 7 database. Work profile included

• Case intake and case triage of spontaneous, solicited cases from post-marketing sources
• Case intake mailbox management, prioritization
• Case processing (E2B and non E2B ICSRs)