Who we are Together, 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 opportunity

Core 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 qualifications

Bachelor of Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology, anatomy, pharmacology). 

Over 5 years Global experience of pharmaceutical industry or CRO experience and at least 3 years of Pharmacovigilance experience. Additionally, at least 2 year coordinating personnel. 

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 managerial, teamwork, critical thinking and good communication skills. Ability to prioritize, analyze, plan, implement, and adjust goals and objectives to meet. Ability to develop cooperative working relationships with all levels of staff is critical.

How you’ll spend your day

Ensure work is properly organized, and undertaken in a manner that meets all requirements of the Health Authorities in US and Canada, and other applicable regulations issued by other government Health Authorities throughout the world, with respect to pharmacovigilance activities. 

Provide ongoing advice and guidance to department personnel.  

Conduct performance appraisals to direct reports, provide input to performance appraisals for indirect reports, and ensure all other full-time regular group personnel are included in a performance management exercise, as per company guidelines and procedures. 

Ensure NA Operations a employees are adequately trained and equipped with required tools to perform their job. 

Support direct and indirect reports with career development and learning goals.   

Act as a back-up for direct reports during absences from the office due to vacations, illness, offsite meetings, or attendance at educational events such as seminars/symposia.   

Intake 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 

Perform daily, weekly, and/or monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments where required 

Other essential duties include drafting pharmacovigilance agendas and meeting minutes, accurately archiving pharmacovigilance documents 

Reports To

PV Operations & Compliance Sr. Manager  

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