Sr. Associate Global Safety - Pharmacovigilance

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr. Associate Global Safety

What you will do

Lets do this. Lets change the this vital role you will carry out core safety activities including data collection processing distribution and regulatory submissions in Argentina. This role requires appropriate training and assigned responsibilities within the safety database and related systems.

Key responsibilities

• Safety Case Management: perform capture process translate distribute and follow-up of adverse event reports in Argentina ensuring their inclusion in the Global Safety database.
• Regulatory and Compliance Assurance: ensure compliance with local safety legislation and internal company policies and procedures.
• Regulatory Authority and Audit Support: support audits regulatory inspections and other pharmacovigilance interactions with local Health Authorities maintaining inspection readiness.
• Support to the Safety Country Lead: assist in the implementation of pharmacovigilance agreements vendor/distributor contracts and safety training for staff contractors local medical teams and/or business partners.
• Safety Reporting and PSUR Management: support the timely submission and distribution of reportable adverse event reports and periodic safety reports (PSURs) for local and/or regional needs as well as urgent safety communications (DHPCs DILs) and other regulatory requirements.
• Risk Management Plans (RMPs) and Risk Minimization: maintain awareness of current risk management plans and support their local implementation. Including execution of risk minimization measures such as safety communications physician education and other activities associated with approved RMPs.
• Review of Local Studies and Programs: assist in reviewing protocols of interventional and non-interventional studies patient support programs and market research projects to ensure safety monitoring and reporting requirements are met.
• Monitoring of Local Medical Literature and Product Safety Support: contribute to the surveillance of local medical literature and Amgen websites/social media projects for potential safety information while also developing product expertise supporting responses to safety-related questions and participating in local medical meetings on product safety.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The Sr. Associate Global Safety we seek is a professional with these qualifications.

Basic Qualifications:

Masters degree

OR

Bachelors degree and 3 years of professional experience as a health care professional (doctor pharmacist nurse vet)

Preferred Qualifications:

• Minimum of 3 years of hands-on experience in conducting local pharmacovigilance activities including adverse event reporting case processing and regulatory submissions.
• Solid understanding of local pharmacovigilance regulations and compliance requirements.
• Proven ability to work with safety databases and contribute to the development and maintenance of pharmacovigilance systems.
• Strong ability to identify prioritize and escalate safety issues is essential for success in this role.
• Proactive attitude innovative mindset and strong communication skills.
• Strong command of written and spoken English is essential.

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.