Jignashu Shah Email & Phone Number

Accomplished professional with a proven track record in Drug Safety leadership, overseeing Patient Support Program teams. Expertise includes client relationship management, compliance with regulations, and development of controlled documents. Skilled in financial management, team performance monitoring, and fostering collaboration. Proven ability to ensure client compliance, meet key performance indicators, and maintain audit-ready activities. Adept at reviewing reports, resolving client issues, and implementing effective project strategies. Recognized for providing technical expertise in database maintenance and developing staff for enhanced Drug Safety services. Actively engage as a primary client contact, address inquiries promptly, and conduct client services presentations and training sessions.

Oakville

• Manage daily and on-going client reporting and project communications for completion, accuracy, and timing deadlines – currently managing 25+ accounts across multiple therapeutic areas• Building and maintaining working relationships with other department and networks to promote Drug Safety goals

• Planed, developed, monitored, tracked and documented milestones and key projects and assignments• Created a stable, productive, and highly engaged team with low attrition rate• Provided leadership and vision and motivated cross-functional project teams to achieve corporate goals though the implementation of the pharmacovigilance program plans

Burlington, Ontario

• Recorded, processed and reviewed 30+ Individual Case Safety Reports (ICSR) and Product Quality Complaints (PQC) per day on Pharmacovigilance Database• Ensured all team members are trained on the pharmacovigilance training materials, client-linked trainings, Standard Operating Procedures (SOPs) and the team continuously met and exceeded performance standards• Improved quality of case reports and assisted the team for consistently meeting 99% compliance rate• Ensured KPI’s are within performance expectations and coach to them as needed

* Receive, triage, review and process data from various sources on time, and meet quality standards.* Perform data entry for tracking of safety database, writing descript case narratives, generating queries pertinent to the case, performing quality control checks, procure reconciliation reports, non-events closure, coordinating translations.* Submitted and processed drug safety information in the pharmacovigilance database system and expedited reports to external clients and regulatory agencies as needed.* Respond and follow-up on requests for information on adverse drug events and clinical description.* Receive and document incoming telephone calls, faxes and emails from various sources reporting the adverse drug events.

* Worked under GMP and SOP requirements and performed documentation procedures using batch manufacturing records, production logs, etc.* Performed control process start up, shut down and trouble shooting.* Identified problems and took steps to shut down, isolate and prepare process units and production units for maintenance.* Ensured products adhered to quality standards, reported any deviations and failures, discarded defective products.

* Support pharmacovigilance activities in compliance with regulatory guidelines.* Preparation of common technical documents (CTD) and periodic safety update reports (PSURs).* Literature review of medical journals and other scientific literatures.* Case entry into the pharmacovigilance database.* Assist with classification of adverse drug reactions.* Process serious adverse events reports.* Obtain medical reviews of SAEs from the panel.* Generate patient narratives.* Code SAEs and the drug data on the SAE forms according to the coding dictionaries used for the study.* Support for the safety related queries including medical telephone inquiries.* Work with Medical Directors/Safety Physicians as needed for medical monitoring activities such as:o collection and review end point packageso review and follow-up lab alertso review and follow-up patient eligibility for inclusion/exclusion in clinical trialso review and follow-up protocol violationso review and study specific model ICFs according to ICH/GCP criteria

Master'S Degree, Pharmacology

Activities and Societies: Activities related to Pharmacology research

Bachelor'S Degree, Pharmacy

Activities and Societies: Management and Editorial