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 findings

What we expect of you

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

Basic Qualifications:

• Doctorate Degree

• Master’s degree and 2 years of directly related experience or

• Bachelor’s degree and 4 years of directly related experience or

• Associate’s degree and 8 years of directly related experience or

• High school diploma / GED and 10 years of directly related experience

Preferred Qualifications:

• Previous experience directly managing teams, projects, programs or directing the allocation of resources.

• Understanding of global regulatory requirements for pharmacovigilance

• Project leadership experience

• Competence in safety systems

• Experience in supporting inspections or internal audits

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

What you can expect from 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, 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:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

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

careers.amgen.com

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.

Application deadline

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

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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