Job Description

Position description

Job Title

Vigilance Evaluation Specialist

Company Details

Septodont is a leading manufacturer of dental pharmaceuticals and medical devices. The French-based company employs over 2,000+ people globally. We have six manufacturing plants in France, India, North and South America, and an international distribution network that is dedicated to serving the needs of dental professionals in more than 150 countries.

Our Cambridge, Ontario site is also home to our Novocol Pharma division, which focuses on contract development and manufacturing, specialized in sterile injectable cartridge and combination product manufacturing.

Our employees are our number one asset! We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.

Job Summary

Reporting to the Corporate Vigilance Evaluation Manager, the Corporate Vigilance Evaluation Specialist (pharmacovigilance, materiovigilance, cosmetovigilance):

• Develops and maintains the risk management system related to the risk tolerance of Septodont products, with a focus on monitoring the risk-benefit levels of the products and proposing system implementations
• Supports the Corporate Products Benefit Risk Monitoring Manager in maintaining the safety of products, ensuring product information is aligned with product profiles
• Maintains the compliance vigilance system for drugs, medical devices and cosmetic products with international regulations (U.S, Canada and Europe), for which Septodont has marketing authorization and/or for products under development, in compliance with Septodont\'s standards as per product risk- benefit assessments
• Collaborates with subsidiaries and distributors

Responsibilities

• Medical review
• Support the Corporate Vigilance Evaluation Manager in maintaining vigilance knowledge among the team
• Lead the maintenance of the risk-benefit system, signal detection and risk management
• Communicate signals internally, to relevant authorities and to partners
• Provide risk-benefit reports of the products
• Coordinate and provide answers to requests from health authorities concerning the risk-benefit profiles of products
• Write the risk management plans and implement minimization activities
• Update or create documents for the maintenance of registrations, write the sections relating to tolerance and risk profiles, prepare conclusions of the assessments for the risk-benefit balance
• Update the internal product tolerance document(s) (CCDS/CCSI/DCSI)
• Ensure the maintenance of safety reports or summary reports in accordance with the regulations in force
• Collaborate in measuring the performance of the system
• Perform impact analysis of the regulation on the risk-benefit vigilance system and implement the actions accordingly to ensure compliance with the regulations
• Support the organization in business continuity for the risk-benefit perimeter
• Observe and support all safety guidelines and regulations

Qualifications

• University degree in a related science (Biology, Chemistry, Pharmaceutical Science)
• 2-3 years of practical experience in Pharmacovigilance
• Knowledge of Pharmacovigilance database software

Knowledge of MedDRA and IMDRF/DPC dictionaries
Proven leadership skills
Excellent interpersonal skills
Strong English Communication skills (written and verbal)
Ability to communicate, read and write scientific papers
Ability to work in multidisciplinary, international teams
Strong analytical and summarization skills

For internal applicants: Please note this is a Level 10 position.

Contract type

Permanent

Candidate criteria

Minimum level of education required

4- Master

Minimum level of experience required

6-10 years

Languages

English (2- Business fluent)

Septodont