Are you passionate about ensuring the safety and well-being of patients? Do you have a keen eye for detail and a strong understanding of drug safety regulations? Novo Nordisk is seeking a skilled Drug Safety Specialist to join our team. As a Drug Safety Specialist, you will play a critical role in monitoring and evaluating the safety of our products, ensuring that they meet regulatory requirements and uphold our commitment to patient safety. If you are dedicated, detail-oriented, and have a strong background in pharmacovigilance, we encourage you to apply for this exciting opportunity.
- Monitor and evaluate the safety of Novo Nordisk products in accordance with regulatory requirements and company standards.
- Conduct thorough review and analysis of adverse event reports to identify potential safety concerns.
- Collaborate with cross-functional teams, including medical, clinical, and regulatory, to ensure timely and accurate reporting of adverse events.
- Maintain up-to-date knowledge of drug safety regulations and guidelines to ensure compliance in all activities.
- Contribute to the development and implementation of drug safety processes and procedures to improve efficiency and effectiveness.
- Provide safety expertise and support for product labeling and risk management plans.
- Prepare and submit safety reports to regulatory authorities in a timely manner.
- Collaborate with global drug safety teams to ensure consistency and alignment of safety processes and procedures.
- Participate in internal and external safety audits and provide support for regulatory inspections.
- Continuously monitor and assess the safety profile of Novo Nordisk products, identifying and communicating any potential safety issues to relevant stakeholders.
- Support the development and implementation of training programs on drug safety for internal stakeholders.
- Maintain accurate and complete records of all drug safety activities in compliance with company policies and procedures.
- Provide safety input for new product development and post-marketing surveillance activities.
- Act as a subject matter expert on drug safety for internal and external stakeholders.
- Participate in cross-functional initiatives to continuously improve drug safety processes and procedures.
Bachelor's Degree In A Relevant Scientific Discipline, Such As Pharmacology, Pharmacy, Or Biology.
Minimum Of 2-3 Years Of Experience In Drug Safety Or Pharmacovigilance In The Pharmaceutical Industry.
Knowledge Of Global Regulations And Guidelines Related To Drug Safety, Such As Ich, Fda, And Ema.
Strong Analytical And Problem-Solving Skills, With Attention To Detail And Ability To Handle Complex And Sensitive Information.
Excellent Communication And Teamwork Abilities, With The Ability To Collaborate Effectively With Cross-Functional Teams And External Partners.
Risk Management
Data Analysis
Drug development
Regulatory compliance
Medical coding
Clinical Trials
Drug Safety
Pharmacovigilance
Safety Reporting
Signal Detection
Adverse Events
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Drug Safety Specialist in Chicago, IL, USA is $79,000 - $108,000 per year, with a median salary of $94,000. This may vary depending on experience, education, and specific job responsibilities.
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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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