Pharmacovigilance Operations Sr. Manager

Amgen is seeking a Pharmacovigilance Operations Sr. Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more:

The Pharmacovigilance Operations Sr. Manager will be on point for the following:

• Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
• Submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors
• Support interactions with, business partners (license partners) and vendors for all case intake and processing activities
• Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures
• Ensure vendor compliance with approved processes and training requirements
• Audit & external inspection support

Responsibilities and Duties:
• Line Management of Case Management staff
• Management of all ICSR processing globally for clinical trial and post-market cases by all case processing teams
• Ensure Vendor delivers high quality cases in a timely manner to meet all worldwide regulatory authority requirements
• Provide vendors with resources and training to perform their role
• Analysis and communication of case QC results
• Management of business partner relationships for case management
• Accountable for contract wording for case related data exchange
• Ensure compliance with contractual wording for case related data exchange
• Escalation of case related issues
• Providing subject matter expertise in the interpretation of regulations as it relates to case intake and processing
• Providing audit/inspection support for case management related activities
• 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

Key Activities:

• Day-to-day issues management for vendors
• Ensure on-boarding and on-going training of vendors
• Attend management meetings with vendors
• Oversee performance monitoring and relay metrics to vendors
• Oversee workload management for vendors
• Analysis of QC trends including actions/recommendations
• Generate, communicate, and archive report of QC findings
• Case intake and processing global SME for safety agreements and Contracts

• Support US Case Follow Up activities
• Oversight for Business Partners interactions for Case Management

• Perform BP reconciliation as required by safety agreement
• Ensure and oversee safety data reconciliation as required by safety agreement
• Ensure performance/compliance metrics are generated, distributed and archived
• Ensure late cases are investigated and documented appropriately
• Ensure quality check of inspection documents for single case outputs
• Provide subject matter expertise in the interpretation of regulations as related to case processing
• Audit/inspection response SME for case related findings
• Ensure audit CAPAs and other actions/recommendations for ICSR processing, quality related measures and compliance issues are completed
• Actively participate and support audits/inspections

Knowledge and Skills:

• Proficiency in global regulatory requirements for pharmacovigilance
• Extensive people management experience
• Expertise in all aspects of case management
• Experience in managing business partner relationships
• Experience in managing/supporting inspections

• Presentation and communication skills

• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

Basic Qualifications:

Doctorate degree and 2 years of directly related experience
OR
Master's degree and 6 years of directly related experience
OR
Bachelor's degree and 8 years of directly related experience

OR

Associate's degree and 10 years of directly related experience

OR

High school diploma / GED and 12 years of directly related experience
AND
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.