DESCRIPTION:

Zenith PV Solutions Inc. is a leading provider of a full range regulatory and pharmacovigilance services to the pharmaceutical industry in Canada. To support our rapid growth, we are looking for a pharmacovigilance (PV) Associate II responsible for monitoring the ADR mailbox, report AEs and PTCs, draft and prepare aggregate reports (ASRs, PSURs, RMPs), and handle SOP revisions among other tasks. In this role, you will work closely with internal Zenith functions and partners at the client companies to ensure compliance to Health Canada GVP requirements.

REQUIRED QUALIFICATIONS AND EXPERIENCE:

• Advanced English is a must. French proficiency (verbal and written) is an asset
• Canadian University degree Bachelor of Science (BSc.) in Pharmacology, Health Sciences or other relevant degree is preferred
• Advanced knowledge of local pharmacovigilance regulations
• 5-7 years of relevant PV/Med Info experience in the pharmaceutical or health care 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
• Clear communication skills are highly valued
• A focus on quality, accuracy and results orientation will be key to your success at Zenith.

• Monitor the safety mailbox as required
• Handle and document incoming AEs in the internal safety database and in accordance with client-specific process
• Handle follow-up information as required for AEs and product technical complaints
• Document and process cases in the safety database
• Perform health authority reporting, as applicable
• Perform periodic literature search
• Perform periodic Health Authority Database (CVD) screening for AE identification
• Perform periodic reconciliation of AEs in accordance with internal process and client requirements
• Support drafting of safety aggregate and signal management reports (ASRs, RMPs ..etc.)
• Draft PV SOPs for assigned clients and contribute to designing the PV activity workflow
• Assist Director of RA, PV & Compliance with other projects as requested
• Interact with other functional areas/departments as applicable
• Comply with Good Documentation Practices through consistency and accuracy of all records