Alka Thakur

Background

About Alka Thakur

A detail-oriented, motivated professional with over 7 years of experience in Drug Safety, Medical Writing, quality assurance, cross-functional team leadership, and regulatory compliance within pharmaceutical and healthcare industries. Worked as a team leader in pharmacovigilance operations and global regulatory compliance, with over seven years of leadership in ICSR teams, including medical writing, quality, regulatory intelligence, signal detection, and literature review. As a skilled leader, I have spearheaded cross-functional collaborations, developed and implemented SOPs, and supervised audits and inspections, including FDA, EMA, and MHRA reviews, ensuring regulatory readiness and operational excellence. Proficient in tools like Veeva Vault and pharmacovigilance databases, I excel in streamlining processes, conducting data analytics, and managing quality systems for continuous improvement. Academically, I hold advanced certifications in Process Quality Engineering and Project Management from Canadian institutions, complemented by a Master's in Biotechnology. Recognized multiple times for outstanding performance, I am passionate about driving innovation, maintaining compliance, and exceeding client expectations in clinical and pharmacovigilance operations.