Director, Pharmacovigilance Operations (MariTide Lead)

Director, Pharmacovigilance Operations (MariTide Lead)

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

In this vital role you will act as US / EU local safety office and FDA / EMA point of contact for safety reporting. Responsible for overseeing the processing and submission of all individual case safety reports to FDA / EMA, business partners (license partners), and vendors. Oversee all interactions with business partners (license partners) and vendors for all case intake and processing activities. Oversee vendor oversight of all intake case processing for adverse events, and intake / triage of product complaints, including analysis and reporting of trends in quality measures for rare disease portfolio. Ensure vendor compliance with approved processes and training requirements. Provide audit and inspection support.

• Act as business process owner (BPO) and point of contact AE Intake processes including training, controlled documents and systems for MariTide platform and for Rare Disease portfolio
• Provide Safety Intake expertise for Data Element Standards Committee relating to development and execution of compliant eCRF / CRFs that facilitate accurate and complete clinical trial SAE data and post market AE data are collected in line with global regulatory requirements
• Ensure all Amgen BP / LP PVAs are compliant with global safety legislation and requirements and meet all case management
• Oversee relationship between business partners (external) and PSAM (internal) to ensure capture of all adverse event data generated under PVAs.
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• ICMC point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Lead and drive ICMC subject matter expertise for eSAE Governance
• Evaluate and implement process improvement strategies for ICMC
• Own process content, deliverables / outputs, and metrics (i.e. performance, business, and compliance metrics)
• Manage communications within the ICMC / PV Operations department training programs; participates in development and modification of procedures and training material
• Drive audit CAPAs and other actions / recommendations for and compliance issues are completed documents
• Accountable as liaison between clinical trial and Global Patient Safety to ensure capture of all adverse event data generated by such programs
• Responsible for developing and supporting strong cross-functional relationships and communication
• Develop and communicate plans / objectives to others as needed
• Maintain knowledge of adverse event collection and reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods
• Lead / Support the implementation of new eSAE processes and methods within and across Global Patient Safety and Global Development Operations
• Develop and maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Performs other duties related to the position as necessary

We are all different, yet we all use our unique contributions to serve patients. The Pharmacovigilance professional we seek is a professional with these qualifications.

Basic Qualifications : Doctorate degree and 4 years of Drug Safety or Life Sciences experience

Or

Master's degree and 7 years of Drug Safety or Life Sciences experience

Or

Bachelor's degree and 9 years of Drug Safety or Life Sciences experience

Preferred Qualifications : BS, MPH, RN, HCP, or Life Science

8+ years of directly relevant experience (including 6 years of experience in Drug Safety)

Experience in leading and managing teams

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, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities that may include :

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

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

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.