Director, Pharmacovigilance Pv Operations, Obesity - Washington, United States - Amgen

Amgen

Verified Company

Washington, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.

Director, Pharmacovigilance PV Operations, Obesity - US, Remote

Live:

What you will do
Let's do this. Let's change the world.

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.

Job Summary:

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 delivery 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 in compliance 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

Key Activities:

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 crossfunctional 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 as defined in Standard Operating Procedures or as requested by their supervisor

Knowledge and Skills:

Able to effectively represent ideas both verbally and in writing
Expert knowledge of the global safety environment, regulations and guidance
Project and/or Process Management experience & knowledge
Expert understanding of safety data capture, representation and interpretation
Expert knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Able to organize, plan, and prioritize workload for the function

Win:

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Drug Safety professional we seek is a leader with these qualifications.

Basic Qualifications:

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

OR

Master's degree and 8 years of Drug Safety or Life Sciences experience

OR

Bachelor's degree and 10 years of Drug Safety or Life Sciences experience

In addition to meeting at least one of the above requirements, you must ha