Pharmacovigilance

Manage end to end pharmacovigilance operations for assigned clients by overseeing case intake evaluation documentation and closure while ensuring regulatory compliant timelines are consistently met.

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

Graduation in veterinary medicine/ post-graduation in pharmacy or any other life science background. Conduct literature surveillance and critical review activities to support signal detection, safety monitoring, and aggregate report preparation. Elanco Animal Health

Responsible for data entry, seriousness assessment and causality assessment of adverse event reports in the PV database Identifies issues in case processing that may result in a delay in submission and escalates issues to management as appropriate.

Senior Principal Pharmacovigilance Scientist ensures regulatory compliance and safety of Takeda's products by managing large projects, developing innovative solutions, and leading cross-functional teams.

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.