Antakshri Pahwa

• Leads Aggregate Report management for 10 reports, including strategy, review and finalization of aggregate safety reports such as PSURs, DSURs, ACOs, AS for assigned products.
• Generation of line listings from safety database for approximately 30 products.
• Recognizing potential issues in reports and interacting with internal or external contacts to resolve issues.
• Evaluating and incorporating reviewer comments in draft reports and liaising with relevant contributors for resolution of comments.
• Performing quality review of reports.
• Supervised team members to confirm compliance with set procedures and quality requirements.
• Monitored team performance and provided constructive feedback to increase productivity and maintain quality standards.
• Built strong relationships with customers through positive attitude and attentive response.
• Worked with team to identify areas of improvement and devised solutions based on findings.
• Conducted training and mentored team members to promote productivity, accuracy, and commitment to friendly service.

Pharmacovigilance Specialist (Oct 2018 - Dec 2020)

Pharmacovigilance Analyst (Nov 2017 - Oct 2018)

Pharmacovigilance Scientist (Nov 2015 - Oct 2017)

• Maintained strong relationships with external partners such as contract research organizations, fostering effective collaboration on pharmacovigilance projects.
• Participated in internal audits as well as external inspections conducted by regulatory authorities, demonstrating solid understanding of applicable regulations and guidelines.
• Conducted case reconciliation with internal departments, distributors, affiliates and business partners.
• Assisted with preparation and implementation of pharmacovigilance agreements and contracts.
• Provided subject matter expertise to support development of training materials, standard operating procedures, and work instructions within department.
• Assisted in preparation of periodic safety update reports, ensuring timely submission to regulatory authorities.

• Assisted in research for 'Process method for production of levulinic acid from agri-residue waste in single-pot reactor setup'
• Analysed test data and presented findings using charts and graphs.
• Actively participated in lab safety inspections, identifying potential hazards and implementing corrective actions promptly.