Teva Canada Limited Work Values

Daily Duties at Teva Canada Limited:

responsible for overseeing all PV activates including Averse Drug Reaction (ADR) /Adverse Event (AE) data processing, aggregate reports (Annual Summary Reports (ASRs), Periodic Safety Update Report (PSURs) and Periodic Benefit Risk Evaluate Reports (PBRERs)), safety signal detections, Risk Management Plans (RMPs), PV training and PV compliances. also responsible for hiring PV staff. Developed and revised Standard Operation Procedures (SOPs) and Working Instructions that provided standard practices to PV staff that ensured consistency and minimized the errors for their daily pharmacovigilance activities. Prepared and submitted responses for safety information from internal / external stake holders and regulatory agencies including Issue-Related Summary Reports (IRSRs). Reviewed and approved Periodic Safety Updated Reports (PSURs) and Annual Summary Reports (ASRs).Reviewed .trial protocols and Safety Management Plan (SMP) for Phase I to IV studies. Reviewed and approved PSUR writing Plan. Established annual PV training program for company employees that increased awareness of AE/ADR reporting to PV departments. Provided PV training to 3rd parties that ensured reporting AE/ADR reports for Teva Products to Teva PV group which met the reporting timeline. Advised and supported Medical Information and Regulatory Affairs and QA that resolved medical inquiries from customers and labeling issues and product complaints. • Reviewed monthly safety signal detection report generated from Global Safety Detection Group provided recommendations to Global Safety Detection Group if necessary to update labeling for the products. Resolved any issues or queries from PV staff during the data processing, e.g., MedDRA coding, WHO drug dictionary, seriousness and labelling assessments, database and E2B submission trouble-shooting, e-reporting etc. ensuring high quality case reports before submitting to Health Canada and Teva Global Safety Group.

What they like about Teva Canada Limited:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

Pharmacovigilance, Drug safety, Clinical trials , Data Processing, Audit, MedDRA coding, Medical Assessments, Risk Management Plan, Pharmacovigilance compliance, Clinical Research, Safety Database, Project management, Meidcal Writing, PSUR/ PBRER, Signal Detection, Medical Review, GVP, Labeling, Negotiations, Safety Data Exchange Agreements, PV Training, Aggregate Reports, CAPAs, Client Relations, Partnership Development, Consultation, Database Management / Security, Process Improvement, Literature Review, Team Leadership / Motivation, QA/ QC, PV Quality Management System, Recruiting, Communication, Policy Development, Training / Development, Technical Writing, Customer Service, FDA / EMA Audits, ICH / CIOMS / MedWatch Reports

Skills

Management, Coding, Risk Management, HIV, Research, Compliance, Data Processing, Database, Assessments, Audit, Filing

These are some of the questions we asked our climbers about their experiences with Teva Canada Limited: