.Who We AreTogether, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityCore member of the safety team and is responsible for performing pharmacovigilance activities within the North America PV unit, in partnership with the Drug Safety Specialists/Pharmacovigilance Safety Specialists and Pharmacovigilance Managers/Director to receive and review adverse event information for pre and post-marketed products.Your Experience And QualificationsBachelor of Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology, anatomy, pharmacology).1-3 years Global experience of pharmaceutical industry or CRO experience and at least 1 year of Pharmacovigilance experience.Demonstrates proficiency with Microsoft Office Word, Excel, PowerPoint and Adobe Acrobat. Knowledge of PhV IT systems such as Arisg, Argus, Cognos is an added advantage.Demonstrates teamwork, critical thinking and good communication skills.How You'll Spend Your DayIntake of adverse event information, including extraction, upload and intake of XMLs.Performs case registration of adverse event reports by entering searchable information.Sending adverse event information to in license partners within the required timeline as per pharmacovigilance agreement.Collecting additional information from reporters and performing follow-up with health care professionals and consumers.Review and assessment of reportability of the adverse event to FDA/Health Canada as applicable.Receiving, reviewing and performing all necessary actions pertaining to negative acknowledgements for FDA and Health Canada as applicable.Participate in Pharmacovigilance audits and inspections as needed.Drafting and finalizing CAPAs as needed for late submissions and non-compliance with internal processes.Complete all training and SOP/WI reviews in a timely manner.Assist in updating and revising SOPs/WIs whenever processes and procedures are changed to comply with new regulations or to improve procedures of make them more efficient.Train all the new hires in PhV on systems and processes relating to pharmacovigilance activities and present information/training in Face-to-Face settings