Pharmacovigilance

Bachelors degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required.

Bachelors degree in Life Sciences, Pharmacy, Medicine. experience in Pharmacovigilance PV within the pharmaceutical or biotech industry. Proven hands-on experience in PV operations e.g., case processing, signal detection, risk management, safety surveillance

Record and review adverse reactions in the safety database for post marketing and clinical trial reports in accordance with applicable regulatory standards, with high accuracy and quality.

Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP. 

Responsible for leading and overseeing local pharmacovigilance activities, including adverse event case processing, safety reporting to Health Authorities, customer complaint handling, regulatory compliance, data quality, and stakeholder collaboration across clinical development and post-marketing activities.

Experience in Pharmacovigilance and Medical Information regulatory requirements, systems, and processes

Preferred certifications include pharmacovigilance or drug safety training from recognized industry bodies such as DIA or similar professional organizations.

Maintain safety tracking systems and ensure timely completion of assigned activities and deliverables. Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required.

Master degree in Pharmacy, Clinical Pharmacology, Pharmacy Practice, and Clinical Research. Age of the person should not exceed 28 years.