Sr Manager Pharmacovigilance Operations Commercial & Study Liaison
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1 Vacancy
Job Summary
Career Category
SafetyJob Description
HOW MIGHT YOU DEFY IMAGINATION
If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Sr Manager - Pharmacovigilance Operations Commercial & Study Liaison
LIVE
What you will do
In this vital role you will operate as a key strategic partner between Global Patient Safety commercial programs and clinical trial activities. You will ensure that all safetyrelevant information generated through patient support programs market research initiatives and clinical studies is appropriately captured reconciled reported and aligned with regulatory expectations. You will drive crossfunctional collaboration strengthen governance around safety reporting standards and lead the implementation of new processes and methodologies across the Global Patient Safety organization. This position requires strong leadership exceptional communication skills and deep expertise in pharmacovigilance operations.
Key responsibilities include:
- Ensure creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents.
- Serve as primary liaison between clinical trials commercial programs (patient support and market research) and Global Patient Safety to guarantee full collection of adverse event data.
- Initiate and support activities ensuring Global Patient Safety input into commercial initiatives.
- Oversee reconciliation activities between Global Patient Safety and commercial programs to ensure complete adverse event reporting.
- Develop and support strong crossfunctional relationships and communication channels.
- Develop and communicate plans and objectives to relevant partners.
- Maintain indepth knowledge of adverse event collection/reporting processes and safety systems and contribute to continuous improvement of processes and methodologies.
- Lead implementation of new processes and methods across Global Patient Safety.
- Develop and maintain functional area SOPs; contribute to R&D Standards documents where applicable.
- Perform activities delegated by the QPPV as outlined in the PV System Master File and maintain an ongoing state of inspection readiness.
- Provide input to global regulatory contracting groups.
- Act as representative and pointofcontact for Health Authority inspections and Internal Process Audits within the remit of the role.
WIN
What we expect of you
We are all different yet we all use our unique contributions to serve patients.
The pharmacovigilance professional we seek is an experienced leader who brings strong scientific expertise operational excellence and the ability to influence across a global matrix environment. You will thrive in this role if you combine deep subjectmatter knowledge with strong people leadership and the ability to navigate complex fastmoving safety operations.
Basic Qualifications
- Doctorate degree and 2 years of Safety Operations experience;
OR - Masters degree and 6 years of Safety Operations experience.
Leadership Experience
- Minimum 2 years of managerial experience either directly managing people or providing leadership through teams projects programs or resource allocation.
THRIVE
What you can expect of us
As we work to develop treatments that take care of others we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization.
- Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act.
- Generous Total Rewards Plan comprising health finance and wealth work/life balance and career benefits.
Required Experience:
Manager
Key Skills
- Presentation Skills
- Time Management
- Clinical Research
- Communication skills
- GCP
- Infusion Experience
- Managed Care
- Hospice Care
- Conflict Management
- Clinical Trials
- Research Experience
- Home Care
About Company
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 ... View more
