Aejad Sheikh

Dynamic pharmacovigilance and medical safety professional with over 9 years of comprehensive experience in ICSR case processing, medical safety review, and benefit-risk assessment. Expertise in signal detection, aggregate safety evaluation, and narrative clarification is complemented by a proven ability to lead teams, reduce backlogs, and ensure compliance with global regulatory standards. Strong collaboration skills with cross-functional teams and global partners facilitate the integration of safety insights into study designs and development plans. Recognized for excellence with multiple Star Performer awards and advancement through the Wings talent development program, dedicated to enhancing patient safety through proactive risk management and high-quality medical oversight.

Suraj Nagar, Nagpur, Maharashtra 440013
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Languages
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Skills
Work Experience
Team Lead medical safety / Process Expert
Tata Consultancy Services
Jul 2017 — PresentCurrentNagpur, Maharashtra
  • Directed a team that reduced a backlog of ~4,000 ICSR cases to just 300 through strategic mentoring and assignment management.
  • Documented and managed Corrective and Preventive Actions (CAPA) from licensing partners, minimizing regulatory delays
  • Monitored team performance, coordinated assignments, and ensured adherence to quality and compliance standards
  • Managed monthly and quarterly reconciliation with global licensing partners, ensuring accurate matching of ICSRs and resolving discrepancies to maintain data integrity
  • Served as the central contact for complex safety data queries and regulatory authority inquiries
  • Streamlined operations during transition to the Argus safety database, addressing surges in late record volumes
  • Processed diverse pharmacovigilance cases (spontaneous, post-marketing, legal), consistently achieving daily processing and accuracy standards
  • Conducted routine quality assessments to confirm full compliance with international regulations and internal SOPs
Skills
Pharmacovigilance OperationsRegulatory ComplianceCAPA ManagementTeam LeadershipSubmission MonitoringData ReconciliationStakeholder CommunicationProcess ImprovementMS OfficeDatabase Transition ManagementTeam Leadership & TrainingSubmission Monitoring (NACK/ACK Resolution)Data Reconciliation (Licensing Partners)Advanced MS Office (Excel, Word, PowerPoint)
Education
Master of Pharmacy, Pharmacology
Nagpur University
Bachelor of Pharmacy
Kishoritai Bhoyar College of Pharmacy
Diploma in Pharmacy
Kusumtai Wankhede Institute of Pharmacy
Languages
English
Fluent
Hindi
Fluent
Marathi
Fluent
Accomplishments
Cleared the internal talent development exam 'Wings,' leading to promotion as Process Expert.
Qualified in the all-India GPAT entrance exam by AICTE; received stipend during Master’s program.
Awarded 'Star Performer' five times for outstanding quality and productivity.
Winner of the quiz competition on security, privacy, and compliance SOPs.