Teva Pharmacovigilance Coordinator 

Mexico, Mexico City 

836796133

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.

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.

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

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

PV Operations & Compliance Sr. Manager

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