Location: Hybrid 2-3 days in-office work/downtown Toronto
Type: Full-time, permanent (No Health Benefits)
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 and the USA. 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 Specialist to support with assigned routine PV and medical information 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:
- Act as the main point of contact for multiple assigned projects
- Act as back-up SME (subject matter expert) for assigned projects, as required
- Monitor the safety mailbox, handle email acknowledgement and other client communications
- Handle and document incoming AEs, medical queries and product complaints 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 screening for AE identification
- Perform periodic reconciliation of AEs and PTCs in accordance with internal process and client requirements
- Develop aggregate reports and signal management reports (ASRs, RMPs ..etc.), as required
- Ensure consistency across multiple projects, Monitor and maintain project KPIs
- Proactively flag project non-conformances, due dates and KPIs at risk
- Support in proactively identifying solutions and addressing issues related to project deliverables
- Support drafting of PV SOPs for assigned clients and contribute to designing the PV activity workflow
- Demonstrate ownership to process improvements, proactive risk/gaps identification and resolution to project deliverables
- Assist the manager 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
Required Qualifications and Experience:
- Accountability and ownership of assigned projects
- Demonstrate proactivity and initiative in identifying gaps and proposing improvements
- Adhere to timelines and deliverables for time sensitive and non-time sensitive tasks
- Great communication, multitasking and organizational skills
- Advanced English proficiency (verbal and written) is a must
- University degree Bachelor of Science (BSc.) in Pharmacology, Health Sciences or other relevant degree. Canadian degree is preferred
- Advanced knowledge of Canadian pharmacovigilance regulations
- Minimum of 7 years of relevant PV experience in the pharmaceutical industry
A focus on quality, accuracy and results orientation will be key to your success at Zenith.
Zenith's Commitment:
We're committed to fostering a culture of excellence and integrity, where your contributions directly impact patient safety and client satisfaction.
If you're driven to make a difference and value a collaborative environment, we invite you to apply in confidence. Send your resume and a role specific motivational letter to [email protected]
Zenith PV Solutions Inc. is an equal opportunity employer, valuing diversity and inclusivity.
Only candidates who meet our screening criteria will be contacted.
Job Type: Full-time
Education:
- Bachelor's Degree (required)
Language:
Work Location: Hybrid remote in Toronto, ON M5C 1X6
