
Drug Safety Specialist
Are you passionate about ensuring the safety and well-being of patients? Do you have a strong background in drug safety and pharmacovigilance? If so, we have an exciting opportunity for you to join our team as a Drug Safety Specialist at Novo Nordisk.In this role, you will play a critical role in protecting the health and safety of patients by managing the collection, evaluation, and reporting of adverse events related to our products. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and support the development of new and existing products.To be successful in this position, you must have a degree in a scientific or healthcare field, along with 2-3 years of experience in drug safety and pharmacovigilance. You should also have a strong understanding of FDA and other global regulations, excellent communication skills, and the ability to work independently as well as part of a team.If you are looking for a challenging and rewarding career in the pharmaceutical industry, we encourage you to apply for the Drug Safety Specialist position at Novo Nordisk. Join us in our mission to make a difference in the lives of patients worldwide.
- Manage the collection, evaluation, and reporting of adverse events related to Novo Nordisk products.
- Ensure compliance with FDA and other global regulations for drug safety and pharmacovigilance.
- Collaborate with cross-functional teams to support the development of new and existing products.
- Conduct thorough and timely review of adverse event reports to ensure accuracy and completeness.
- Communicate with healthcare professionals and regulatory authorities regarding adverse events as necessary.
- Maintain accurate and up-to-date records of adverse events and safety data.
- Participate in the development and implementation of safety protocols and procedures.
- Monitor and analyze safety data trends to identify potential safety issues and make recommendations for risk mitigation.
- Train and mentor team members on pharmacovigilance processes and regulations.
- Contribute to the preparation of regulatory submissions and responses to inquiries related to drug safety.
- Keep abreast of changes in regulations and guidelines related to drug safety and pharmacovigilance.
- Communicate effectively with internal and external stakeholders, including cross-functional teams, regulatory agencies, and healthcare professionals.
- Ensure timely and accurate reporting of adverse events to regulatory authorities.
- Participate in audits and inspections related to drug safety and pharmacovigilance.
- Adhere to company policies, procedures, and ethical standards in all aspects of job performance.
Bachelor's Degree In Pharmacy, Pharmacology, Life Sciences, Or Related Field
Minimum Of 2-3 Years Of Experience In Pharmacovigilance Or Drug Safety Within The Pharmaceutical Industry
Knowledge Of Global Regulatory Requirements For Drug Safety Reporting, Including Fda, Ema, And Ich Guidelines
Strong Analytical Skills And Ability To Review And Interpret Safety Data From Clinical Trials And Post-Marketing Surveillance
Excellent Communication And Teamwork Skills, With The Ability To Collaborate With Cross-Functional Teams And Effectively Communicate Safety Information To Internal And External Stakeholders.
Risk Management
Regulatory compliance
Medical coding
Pharmacovigilance
Adverse Event Reporting
Safety Assessments
Drug Safety Monitoring
Signal Detection
Case Processing
Drug Safety Databases
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Drug Safety Specialist in Toronto, ON, Canada is between $60,000 and $80,000 per year. However, this can vary depending on factors such as experience, education, and the specific company or industry. Senior level Drug Safety Specialists may earn higher salaries, potentially reaching up to $100,000 per year.
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Novo Nordisk AS engages in the research, development, manufacture, and marketing of pharmaceutical products. It operates through the Diabetes and Obesity Care; and Biopharmaceuticals segments. The Diabetes and Obesity Care segment covers insulins, glucagon-like-peptide 1, other protein-related products, oral anti-diabetic drugs and obesity. The Biopharmaceuticals segment handles the research, development, manufacture, and distribution of products within the areas of haemophilia, growth hormone, hormone replacement, inflammation and other therapy areas.

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