
Pharmacovigilance Specialist
Welcome to Novo Nordisk, a global healthcare company dedicated to improving the lives of people living with chronic diseases. We are currently seeking a skilled and passionate Pharmacovigilance Specialist to join our team. As a Pharmacovigilance Specialist, you will play a critical role in ensuring the safety and efficacy of our products, and ultimately contribute to our mission of changing diabetes. If you have a strong background in pharmacovigilance and a desire to make a meaningful impact in the healthcare industry, we want to hear from you. Join us in our commitment to innovation, quality, and patient care.
- Monitor and analyze safety data for our products to ensure compliance with regulatory requirements and internal safety standards.
- Conduct thorough and timely evaluations of adverse events, product complaints, and other safety information.
- Collaborate with cross-functional teams to develop and implement risk management plans.
- Act as the primary point of contact for pharmacovigilance related inquiries from regulatory agencies and other stakeholders.
- Stay up-to-date on relevant regulations and guidelines in order to maintain compliance and provide accurate and timely reporting.
- Participate in the development and implementation of safety training for internal teams and external partners.
- Conduct periodic safety signal detection and manage the signal detection process.
- Ensure the timely and accurate reporting of adverse events to regulatory agencies.
- Oversee the preparation and submission of periodic safety reports and other safety-related documents.
- Identify and implement process improvements to optimize pharmacovigilance operations.
- Collaborate with internal and external stakeholders to conduct risk-benefit assessments and communicate safety information.
- Maintain accurate and detailed records and documentation related to pharmacovigilance activities.
- Communicate and present safety data and insights to cross-functional teams and senior management.
- Assist with pharmacovigilance audits and inspections, and address any findings or recommendations.
- Promote a culture of patient safety and continuous improvement within the organization.
Bachelor's Or Master's Degree In Pharmacy, Medicine, Nursing, Or Related Healthcare Field
Minimum Of 3 Years Experience In Pharmacovigilance Or Drug Safety Within The Pharmaceutical Industry
Strong Knowledge Of Global Pharmacovigilance Regulations And Guidelines, Including Ich, Fda, And Ema
Excellent Analytical And Critical Thinking Skills, With The Ability To Identify And Assess Potential Safety Risks
Effective Communication Skills, Including The Ability To Collaborate With Cross-Functional Teams And Present Complex Information To Different Audiences.
Data Analysis
Drug development
Risk assessment
Regulatory compliance
pharmacology
Clinical Trials
Medical Writing
Drug Safety
Safety Reporting
Signal Detection
Adverse Events
Pharmac
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
flexibility
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Pharmacovigilance Specialist in Hauppauge, NY, USA is $85,000 - $105,000 per year. This may vary depending on factors such as experience, education, and the specific company or organization the individual is employed by.
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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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