Pharmacovigilance Training - Toronto, Canada - Johnson & Johnson

Johnson & Johnson

Verified Company

Toronto, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Janssen-Ortho Inc. is recruiting for a Pharmacovigilance (PV) Training & Process Manager, BioAdvance, located in Toronto, Ontario.

As part of BioAdvance team; you will lead/support departmental initiatives and shape the compliance culture with focus on operational excellence, innovation, compliance, talent development, diversity, and inclusion.

Key Responsibilities:

Lead Janssen, Vendor and Departmental PV Training - 60%

Lead training compliance and system access reviews for AE/PQC reporting for BioAdvance contracted manufacturers for the various portals by performing regular user access reconciliation activities.
Establish strong relationships with key contacts for pharmacovigilance initiatives, supporting internal & external audits to ensure appropriate governance over the multiple programs supported by BioAdvance.
Develops metrics for quality management activities and reporting.

PV Reconciliation & Quality Issue & Corrective and Preventive Actions (CAPAs) - 20%

Lead the AEPQC reconciliation to ensure PV obligations have been met
Establish and maintain detailed evidence of activities & share back investigation results with external vendors as per regulatory & manufacturer requirements
Advance resolutions to areas of noncompliance to management & external partners to create Corrective and Preventative Actions Plans (CAPAs) & support CAPAs
Assist in conducting compliance risk assessments, trend analysis, and provide solutions and recommendations for improving quality and compliance

Lead and provide oversight of PV Records Management Activities (10%)

Coordinate, maintain, and advance the records management process and ensure audit readiness & Establish optimal GxP document storage solutions for PV documents
Lead all aspects of the controlled procedural documents creation and periodic revisions in compliance within Regulatory Guidelines, representing internal and external partners on crossfunctional and other team initiatives

People Management & Strategic Leadership:

Lead & design a centralized solution for AE/PQC processing, ensuring regulatory & manufacturer compliance for reporting requirements.
Provide direction to vendors and assigned team members in their daily activities ensure timely and accurate execution completion of assigned tasks
Contribute to the development and implementation of the strategic direction and priorities

Qualifications:

Qualifications:

Minimum Three (3) years of previous experience in a training, compliance or pharmacovigilance, preferably in a regulated environment (pharmaceutical, clinical, other regulated industry) required
Experience leading or supporting Pharma audits and/or board of health inspections with a good understanding of GxP and Health Canada regulations
Experience in handling root cause analysis, investigations and CAPA generation preferred
Excellent organizational & critical thinking skills and attention to detail.
Flexible, adaptable and able to work in a fast paced environment and handling multiple priorities & strick timelines
Demonstrated leadership, initiative and accountability with a proven expertise in evidencebased problem solving and critical thinking, driving process improvements through partner engagement and organizational change.
Excellent communication skills, both written and verbal (English & French) preferred

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies.

Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success.

We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.