Vigilance Evaluation Specialist

4 weeks ago

Cambridge, Canada Septodont Full time

**General information**:
**Reference **:2023-1368

**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

**Contract type**:
Permanent

**Minimum level of education required**:
4- Master

**Minimum level of experience required**:
6-10 years

**Languages**:
English (2- Business fluent)

**Position location**:
**Job location**:
North America, Canada, Cambridge

**Location**:
25 Wolseley Court N1R 6X3 Cambridge

  • Security Badge Specialist

    6 days ago

    Cambridge, Canada Securitas Canada Ltd. Full time

    Position: Security Badge Specialist - Access Badges Reports To: Site Security Manager (SSM) Location: Cambridge, ON Shift: Monday to Friday 07:00-15:00hrs SUMMARY Type and Length of Specific Experience Required: - Must possess a minimum of three (3) years of experience in a badging or similar role - Must possess customer service experience in a security...

  • Hearing Instrument Specialist

    1 month ago

    Cambridge, Canada Whisper Audiology Hearing Clinic Full time

    We are seeking a Hearing Instrument Specialist to join our team. In this role, you will be responsible for helping individuals with hearing loss improve their quality of life by providing them with personalized hearing solutions. **As a part of our team, your responsibilities will include**: Working closely with clients to evaluate their hearing needs,...

  • Hearing Instrument Specialist

    4 weeks ago

    Cambridge, Canada Whisper Audiology Hearing Clinic Full time

    We are seeking a Hearing Instrument Specialist to join our team. In this role, you will be responsible for helping individuals with hearing loss improve their quality of life by providing them with personalized hearing solutions. **As a part of our team, your responsibilities will include**: Working closely with clients to evaluate their hearing needs,...

  • Talent Acquisition Specialist

    4 weeks ago

    Cambridge, Canada Superior Propane Full time

    Reporting to the Manager of Talent Acquisition, the Talent Acquisition Specialist provides support and coordination for Superior Propane’s recruitment process on a national basis. The Talent Acquisition Specialist will maximize the attraction and recruitment of talent by partnering with Hiring Managers and the Human Resources team. The Talent Acquisition...

  • Security Guard-full Time/part Time/floater

    1 month ago

    Cambridge, Canada Securitas Canada Ltd. Full time

    **Securitas Canada Limited** **SECURITY GUARD JOBS Securitas is a global leader in the security industry and has been providing security services since 1899. With over 8,000 employees in 25 District offices across Canada, and 370,000 employees globally, we possess the experience and knowledge to offer a broad range of expert services including: On-site...

  • Quality Specialist

    1 month ago

    Cambridge, Canada Accucam Machining Inc. Full time

    We are currently looking for a Quality Specialist who will be responsible for ensuring that the highest standard is realized at each phase of the manufacturing process; will be responsible for the day-to-day quality control functions, APQP, and related aspects including continuous improvement, issue resolution, preventative and corrective actions, product...

  • Analytical Systems Specialist

    4 weeks ago

    Cambridge, Canada Mundipharma International Limited Full time

    Analytical Systems Specialist page is loaded Analytical Systems Specialist Apply locations GB Cambridge time type Full time posted on Posted 5 Days Ago job requisition id JR1185 Analytical Systems SpecialistContact length: Permanent Location: Cambridge  Department: Quality Control Job type: Full Time Join us and make...

  • Analytical Systems Specialist

    1 month ago

    Cambridge, Canada Mundipharma International Limited Full time

    Analytical Systems Specialist page is loaded Analytical Systems Specialist Apply locations GB Cambridge time type Full time posted on Posted 5 Days Ago job requisition id JR1185 Analytical Systems SpecialistContact length: Permanent Location: Cambridge  Department: Quality Control Job type: Full Time Join us and make...

  • Analytical Systems Specialist

    3 days ago

    Cambridge, Canada Mundipharma International Limited Full time

    Analytical Systems Specialist page is loaded Analytical Systems Specialist Apply locations GB Cambridge time type Full time posted on Posted 5 Days Ago job requisition id JR1185 Analytical Systems SpecialistContact length: Permanent Location: Cambridge  Department: Quality Control Job type: Full Time Join us and make...

  • Analytical Systems Specialist

    4 weeks ago

    Cambridge, Canada Mundipharma International Limited Full time

    Analytical Systems Specialist page is loaded Analytical Systems Specialist Apply locations GB Cambridge time type Full time posted on Posted 5 Days Ago job requisition id JR1185 Analytical Systems SpecialistContact length: Permanent Location: Cambridge  Department: Quality Control Job type: Full Time Join us and make...

  • Underwriting Operations Specialist

    19 hours ago

    Cambridge, Ontario, Canada Gore Mutual Insurance Full time

    We're now at the boldest phase of our Next Horizon journeyAt Gore Mutual, we've completely transformed our business in under three years. By investing in top talent and leading technology, we've redefined what it means to be a modern mutual that does good.Our path forward brings a sharper focus on our business' performance that's powered by innovation and an...

  • Bilingual Credit Collections Specialist

    1 week ago

    Cambridge, Canada Kassen Full time

    Our esteemed client in the manufacturing industry is currently seeking a Credit & Collections Specialist. In this role, you will play a vital part in administering the company’s Credit Policy. The ideal candidate will possess excellent verbal and written communication skills, meticulous attention to detail, and a proactive approach to problem-solving. This...

  • Bilingual Credit Collections Specialist

    1 week ago

    Cambridge, Canada Kassen Full time

    Our esteemed client in the manufacturing industry is currently seeking a Credit & Collections Specialist. In this role, you will play a vital part in administering the company’s Credit Policy. The ideal candidate will possess excellent verbal and written communication skills, meticulous attention to detail, and a proactive approach to problem-solving. This...

  • Bilingual Credit Collections Specialist

    1 week ago

    Cambridge, Canada Kassen Full time

    Our esteemed client in the manufacturing industry is currently seeking a Credit & Collections Specialist. In this role, you will play a vital part in administering the company’s Credit Policy. The ideal candidate will possess excellent verbal and written communication skills, meticulous attention to detail, and a proactive approach to problem-solving. This...

  • Regulatory & Scientific Affairs Specialist

    7 days ago

    Cambridge, Canada Nutrablend Foods Full time

    Meet Nutrablend FoodsNutrablend Foods is one of the largest custom manufacturers of specialized health nutrition powder products in North America, powered by an experienced team with a passion to help customers hustle and thrive. With over 20 years working with some of the top Sports Nutrition brands around the world, our experience supports our customers to...

  • Regulatory & Scientific Affairs Specialist

    4 weeks ago

    Cambridge, Canada Nutrablend Foods Full time

    Meet Nutrablend Foods Nutrablend Foods is one of the largest custom manufacturers of specialized health nutrition powder products in North America, powered by an experienced team with a passion to help customers hustle and thrive. With over 20 years working with some of the top Sports Nutrition brands around the world, our experience supports our customers...

  • Bilingual Credit Collections Specialist

    7 days ago

    Cambridge, Canada Kassen Full time

    Our esteemed client in the manufacturing industry is currently seeking a Credit & Collections Specialist. In this role, you will play a vital part in administering the company’s Credit Policy. The ideal candidate will possess excellent verbal and written communication skills, meticulous attention to detail, and a proactive approach to problem-solving. This...

  • Health, Safety and Environmental Specialist

    7 days ago

    Cambridge, Canada Kromet International Inc. Full time

    Primary Function: Occupational health and safety specialists review, evaluate and monitor health, safety and environmental hazards and develop strategies to prevent, control and eliminate accidents and occupational injuries. They inspect the workplace environments, equipment and practices to ensure compliance with organization and government environment,...

  • Regulatory & Scientific Affairs Specialist

    4 weeks ago

    Cambridge, Canada Nutrablend Foods Full time

    Meet Nutrablend FoodsNutrablend Foods is one of the largest custom manufacturers of specialized health nutrition powder products in North America, powered by an experienced team with a passion to help customers hustle and thrive.With over 20 years working with some of the top Sports Nutrition brands around the world, our experience supports our customers to...

  • Regulatory & Scientific Affairs Specialist

    4 weeks ago

    Cambridge, Canada Nutrablend Foods Full time

    Meet Nutrablend Foods Nutrablend Foods is one of the largest custom manufacturers of specialized health nutrition powder products in North America, powered by an experienced team with a passion to help customers hustle and thrive. With over 20 years working with some of the top Sports Nutrition brands around the world, our experience supports our customers...