Bhawana Mishra

• Led case processing in the ARGUS safety database, ensuring accurate and timely handling of adverse event reports in compliance with Pharmacovigilance (PV) and Medical Device Vigilance (MDV) guidelines and SOPs.
• Analyzed patient medical histories, laboratory results, and other relevant information to assess potential risks associated with medication use.
• Oversaw pharmacovigilance vendor management to ensure consistent quality and compliance with regulatory guidelines, aligning operations with industry best practices.
• Contributed to the development of monthly quality metrics and KPIs, facilitating strategic decision-making and process improvements in Safety Management Plans (SMPs).
• Actively participated in cross-functional meetings, enhancing collaboration and alignment of pharmacovigilance goals, demonstrating strong interpersonal skills and teamwork.

• Implemented consistent, efficient, and quality processes in Pharmacovigilance (PV) to meet timelines and deliverables according to regulatory requirements and Standard Operating Procedures (SOPs)

•Ensured compliance of operations with governing regulatory requirements, maintaining adherence to industry best practices

•Created, maintained, and assumed accountability for a culture of high customer service within the team

•Executed drug safety data management processes including case entry, medical coding, narrative writing, peer review, case follow-up, and report preparation

•Assumed responsibility for the quality of data processed, maintaining accuracy and integrity throughout all tasks

•Managed patient narratives, data entry, and reconciliation of safety data utilizing ARISg safety database

•Conducted regulatory reporting including submissions to MedWatch, CIOMS, and E2B, ensuring timely and accurate submissions.

•Demonstrated a strong understanding of drug and medical device safety regulations, applying knowledge to daily operations

•Utilized MS Office applications for effective communication and documentation

•Collaborated effectively within the team, demonstrating strong interpersonal skills and contributing to a positive work environment