Are you passionate about ensuring the safety of medications and protecting patients' well-being? Do you have a keen eye for detail and excellent analytical skills? If so, we have an exciting opportunity for you to join our team as a Drug Safety Specialist at Novo Nordisk.At Novo Nordisk, we are dedicated to improving the lives of people living with chronic conditions, including diabetes, obesity, and rare blood and endocrine disorders. As a Drug Safety Specialist, you will play a crucial role in helping us maintain the highest standards of drug safety and compliance.To be successful in this role, you must have a Bachelor's degree in a relevant field, such as pharmacy, pharmacology, or life sciences. Additionally, you should have a minimum of 3 years of experience in drug safety, preferably in the pharmaceutical industry.If you are a highly motivated individual with a strong commitment to patient safety and are looking for a challenging yet rewarding career, we encourage you to apply for this position. Join us in our mission to make a difference in the lives of patients worldwide.
- Monitor and review adverse event reports from clinical trials, post-marketing surveillance, and other sources to ensure compliance with regulatory requirements and company policies.
- Perform case processing and assessment of adverse events, including medical review, causality assessment, and coding.
- Collaborate with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory authorities.
- Conduct signal detection activities, including review of safety data, literature, and signal evaluation.
- Assist in the preparation of safety reports, including periodic safety reports and risk management plans.
- Stay up-to-date with relevant regulatory guidelines and requirements for drug safety and pharmacovigilance.
- Participate in safety surveillance activities, including safety data review and safety signal management.
- Conduct quality control checks of safety data and ensure accuracy and completeness of safety databases.
- Communicate with healthcare professionals and patients regarding safety-related issues and provide appropriate safety information.
- Contribute to the development and implementation of drug safety policies and procedures.
- Train and mentor junior drug safety team members as needed.
- Collaborate with other departments, such as clinical development and regulatory affairs, to ensure drug safety requirements are met throughout the drug development process.
- Conduct risk-benefit assessments and provide recommendations for risk management strategies.
- Participate in audits and inspections related to drug safety and pharmacovigilance.
- Handle any other drug safety-related tasks as assigned by the management.
Bachelor's Or Master's Degree In A Relevant Field Such As Pharmacology, Toxicology, Or Pharmacy.
Minimum Of 3-5 Years Of Experience In Drug Safety Or Pharmacovigilance In The Pharmaceutical Industry.
Working Knowledge Of International Drug Safety Regulations, Including Fda And Ema Guidelines.
Ability To Effectively Manage Adverse Event Reporting And Signal Detection Processes.
Strong Analytical And Problem-Solving Skills, With Attention To Detail And Accuracy In Data Management.
Risk Management
Data Analysis
Medical coding
Pharmacovigilance
Adverse Event Reporting
Signal Detection
Drug Safety Regulations
Case Processing
Safety Signals
Benefit-Risk Assessment
Communication
Conflict Resolution
Leadership
Time management
creativity
Critical thinking
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Drug Safety Specialist in London, UK is between £35,000 and £55,000 per year. This can vary depending on factors such as experience, qualifications, and the specific company or industry the individual works in. Senior-level Drug Safety Specialists may earn higher salaries, potentially up to £75,000 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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