Chaitrali Rai

· Scoped projects, defining the strategic approach to meet patient needs and achieve project objectives.

· Reviewed comprehensive protocols that outlined project goals, methodologies, timelines, and deliverables.

· Actively participated in external project management organizations, conferences, and seminars to stay abreast of industry best practices.

· Engaged with professional associations, sharing project management knowledge, and contributing to the advancement of site PMO efforts.

· Responsible for day-to-day work, pharmacovigilance process set up and constantly endeavoring to be able to meet regulatory expectations.

· Participate in audits and regulatory inspections and provide inputs for audit responses.

· Medical Dictionary for Regulatory Activities (MedDRA) coding of adverse events, laboratory data, coding of suspect and concomitant drugs.

· Drafting and reviewing of PADER, PSURs, DSURs, PBRERs and Canadian Aggregate reports.

· Contributed to the review and update of Pharmacovigilance system master file (PSMF) and Risk Management plan (RMPs).

· Monitored and evaluated the effectiveness of training initiatives, adjusting as necessary to enhance outcomes.

· Establish trackable KPIs, maintain and track metrics, reports using data visualization with power BI.

· Periodic evaluation of adverse events for trending analysis of adverse events or therapeutic groups

Technical skills

· Hands on expertise in drug safety database Argus (7.0.2, 8.0.1 and 8.2).

· Mentoring of new hire associates to implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.

· Involved in designing sign off and preparation of training plan for new hires.

· Delivered engaging and informative training sessions, fostering knowledge transfer and skill development on different therapeutic areas like orthopedics, immunology, nephrology, cardiovascular, ophthalmology, orphan drugs and oncology.

· Ensure compliance of operations with governing regulatory requirements. Initiate and support process updates and improvements.

· Participate in the creation of standard process documents and training materials (Ex. SOPs, Project plans, safety management plan (SMP) and work instructions) and ensure stakeholders are trained.

· Support audit activities and the co-ordination of responses to findings as required.

· Execute drug safety data management processes combination of case entry, medical coding, narrative writing, peer review, case follow-up, report preparation and submission to regulatory authorities with accountability for quality and timeliness of deliverables.

· Assess adverse event reports for seriousness, causality, and expectedness. Mentoring of new hire associates; implement consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.

· Cross trained in working on different therapeutic areas like orthopedics, immunology, nephrology, cardiovascular and oncology.

· Technical expertise in drug safety database ARISg (6.3 and 6.6). Triage of incoming cases to determine seriousness for prioritization of daily workflow in IRT.

· To work with Clinical (Solicited) Spontaneous (Unsolicited), NIS and NIP cases. Processing of SUSARs and other special scenario cases (off label, medication error, other safety findings, pregnancy, lack of efficacy)

· Labeling of adverse events using the investigators brochure and other safety reference documents (core data sheet, United States prescribing information (USPI) and summary of product characteristics (SMPC).