KARTHIKA S

I am a proactive and highly motivated, customer-focused Safety Specialist within the Pharmacovigilance domain with over 3.6 years of experience. I have expertise in various areas, including processing and quality review of ICSR cases. I consistently apply the knowledge I have gained while also exploring and learning new areas within the healthcare system.

I hold an integrated post-graduate degree in Pharmacy (Pharm D) from The Tamil Nadu Dr. MGR Medical University, Tamil Nadu, India.

• Work in accordance with the Good Clinical Practices, ICH Guidelines, Standard Operating Procedures (SOP), and Common Terminology Criteria for Adverse Events (CTCAE) governing Human Subject Research.
• Processed safety reports from all sources for assigned products according to ICH-GCP and FDA guidelines.
• Experienced in triage, case processing, duplicate check, data entry, coding of adverse events and drugs, narrative writing, quality check and reporting.
• Proficient in coding of serious and non-serious adverse events using MedDRA terminology and drug coding in accordance with WHO-DD and company core dictionary.
• Experienced in preparing and submission of adverse event reports.
• Good team player, consistent, flexible, committed to work and has the desire to take responsibilities and fulfill them effectively.
• Quick learner, self-motivated, able to work effectively and efficiently in a high pressure, fast paced environment.
• Review and evaluate AE case information to determine required action based on following internal policies and procedures.
• Process all incoming cases to meet timelines.
• Ensure to meet expected productivity and quality standards.
• ADHOC activities including allocation of cases, updating clinical trial documents in company portal from Veeva vault on timely basis.

• A highly optimistic person and proactive
• Hard working and quick learner
• Good interpersonal skill

A Clinical Investigation on the effect of Coenzyme Q10 on the electrocardiography of Cardiac patients under Beta blocker therapy

• Date of Birth :21 Oct1996
• Nationality : Indian
• Gender : Female

I hereby declare that information provided above is true and accurate to the best of my knowledge.

Place: Bengaluru

KARTHIKA S