Teva Pharmacovigilance Associate 

Mexico, Mexico City 

851098462

Bachelor 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.

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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