REQUIRED QUALIFICATIONS AND EXPERIENCE:

· Advanced English proficiency (verbal and written) is a must
· Canadian University degree Bachelor of Science (BSc.) in Pharmacology, Health Sciences or other relevant degree is preferred
· Advanced knowledge of Canadian pharmacovigilance regulations
· 5-7 years of relevant PV experience (RMPs, aggregate reports) in the pharmaceutical industry
· Dynamic workstyle with ability to multitask, prioritize and schedule daily activities with minimal supervision
· Adapt quickly to changes in responsibility, based on client needs, with ability to handle multiple clients and projects effectively
· Advanced communication skills
A focus on quality, accuracy and results orientation will be key to your success at Zenith.

YOUR ROLE:

Zenith PV Solutions Inc. is a leading provider of a full range pharmacovigilance and regulatory affairs services to the pharmaceutical industry in Canada. Our philosophy to provide the best quality of service and focus on client satisfaction has allowed us to grow rapidly through client referrals. As we grow our team to support our growing client base, we are looking for an experienced Pharmacovigilance Associate II (Senior PV Associate) to support with assigned PV activities as described below. You are someone for whom responsibility is second nature, and your profound knowledge in PV not only elevates our team but also secures our clients’ trust and confidence.

MAIN RESPONSIBILITIES:

• Develop aggregate reports such as ASRs and PSURs for the assigned products
• Draft local risk management plans (RMPs) and Risk minimization measures (RMMs)
• Support with the implementations of RMPs, liaising with the relevant internal and external stakeholders
• Support safety signal identification and implementation of appropriate measures
• Perform safety mailbox monitoring and case intake
• Perform periodic literature screening
• Perform periodic Health Authority database screening
• Complete periodic reconciliations in a timely manner per client process or as assigned
• Comply with Good Documentation Practices through consistency and accuracy of all records
• Contribute to writing and updating relevant SOPs as needed
• Assist with other projects as requested
• Interact with assigned client partners and other internal functional departments for timely completion of assigned tasks