Are you passionate about ensuring the safety of patients worldwide? Do you have a strong understanding of global pharmacovigilance regulations and experience in drug safety? If so, Amgen has an exciting opportunity for you as a Global Pharmacovigilance (PV) Scientist. As a member of our dynamic PV team, you will play a vital role in monitoring and evaluating the safety of our products, ultimately contributing to the overall success and growth of our company. We are seeking a highly qualified individual with a keen attention to detail, excellent communication skills, and a dedication to upholding the highest standards of patient safety. If this sounds like you, we encourage you to apply and join us in our mission to serve patients and make a positive impact on the world of healthcare.
- Monitor and evaluate the safety of Amgen's products in compliance with global pharmacovigilance regulations.
- Conduct thorough safety assessments of adverse events and potential safety signals related to Amgen's products.
- Collaborate with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory authorities.
- Develop and maintain risk management plans for Amgen's products.
- Stay updated on current pharmacovigilance regulations and guidelines to ensure compliance.
- Communicate any safety concerns or updates to relevant internal and external stakeholders.
- Conduct safety reviews of clinical trial protocols, study reports, and other relevant documents.
- Participate in the development and implementation of pharmacovigilance processes and procedures.
- Collaborate with global partners to ensure consistent and timely exchange of safety information.
- Act as a subject matter expert on pharmacovigilance matters and provide guidance to other team members.
- Contribute to the continuous improvement of pharmacovigilance processes and systems.
- Maintain accurate and up-to-date records of all safety data and documentation.
- Participate in training and education initiatives related to pharmacovigilance for internal and external stakeholders.
- Uphold the highest standards of patient safety and ensure all activities are conducted with integrity and in line with company values.
- Take on additional duties and responsibilities as needed to support the overall success and growth of the company.
A Degree In Pharmacy, Medicine, Or A Related Life Science Field.
Knowledge Of Global Pharmacovigilance Regulations And Guidelines, Including Ich, Fda, And Ema.
Experience In Pharmacovigilance, Drug Safety, Or Clinical Research In The Pharmaceutical Industry.
Strong Communication And Collaboration Skills, With The Ability To Work Effectively In A Global, Cross-Functional Team.
Proficiency In Data Analysis And Signal Detection, With Experience Using Pharmacovigilance Databases And Software.
Data Analysis
Risk assessment
Regulatory compliance
pharmacology
Clinical Trials
Medical Writing
Drug Safety
Safety Reporting
Signal Detection
Adverse Events
Pharmacovigilance Systems
Communication
Conflict Resolution
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Global Pharmacovigilance (PV) Scientist is between $90,000 and $140,000 per year. This may vary depending on factors such as experience, location, and specific job responsibilities.
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Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.

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