Pharmacovigilance Operations Manager

Career Category

Job Description

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 mission—to serve patients living with serious illnesses—drives 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Pharmacovigilance Operations Manager

What you will do

In this vital role your primary responsibility will be acting as US/EU local safety office and FDA/EMA point of contact for safety reporting.

You will support the submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors

Supporting interactions with business partners (license partners) and vendors for all case intake and processing activities.

Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures.

Ensuring vendor compliance with approved processes and training requirements.

Audit & external inspection support 

Key responsibilities include:

• Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements

• Provide vendors with resources and training to perform their role

• Support the analysis and communication of case QC results

• Lead development and delivery of training materials for case management conventions

• Support resolution of case related specific queries

• Management of multiple business partner relationships for case management

• Support reviews of contract wording for case related data exchange

• Monitoring compliance regarding regulatory submissions and/or contractual wording for data exchange

• Assign tasks within Case Management to direct and indirect reports

• Support management of staff within Case Management

• Escalation of case processing issues

• Audit & external inspection support

• 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 as defined in Standard Operating Procedures or as requested by his/her supervisor

• Day-to-day vendor management issues

• Interact with other local safety offices

• Ensure case processing timelines for AE intake, triage and submission are met

• Assess workload to assist in resource management

• Support on-boarding and on-going training of vendors

• Attend management meetings with vendors

• Support analysis of QC trends

• Support generating, communicating, and archiving of reports of QC findings

• Support audits of CAPAs and other actions/recommendations for ICSR quality related measures

• Perform case review as required

• Lead development and delivery of convention-related training material

• Support training of local office staff 

• Perform US case follow up activities

• Perform BP reconciliation as required by safety agreement

• Generate and distribute performance metrics (submission compliance, volumes, turnaround times)

• Support reviews of contract wording for case related data exchange

• Support regulatory inspection and support for vendor audits/inspections

• Oversee performance monitoring and relay metrics to vendors

• Support analysis of QC trends including actions/recommendations

• Generate, communicate, and archive report of QC f