Global Safety Senior Manager QQPV Office

Career Category

Job Description

Join our team at AMGEN Capability Center Portugal number 1 company in Best WorkplacesTM ranking in Portugal in 2024 (category 201-500 employees) by the Great Place to Work Institute. We have a team of over 500 talented people and more than 40 different nationalities diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity Data & Analytics Digital Technology and Innovation Finance General & Admin Human Resources Regulatory Affairs and many Lisbons city center our AMGEN office fosters innovation excellence and inspiration. Come thrive with us at AMGEN supporting our mission To Serve Patients. What we do at AMGEN matters in peoples lives.

GLOBAL SAFETY SENIOR MANAGER - QQPV Office

LIVE

WHAT YOU WILL DO

In this vital role the Global Safety Senior Manager is responsible for providing operational support to the Qualified Person for Pharmacovigilance Office (QPPV Office) to facilitate oversight of the AMGEN Pharmacovigilance (PV) system. You will ensure back-up procedures are initiated in the EU and followed if contact with EU QPPV is requested by the agency or relevant competent authority. This position reports directly to the EU QPPV.

Key responsibilities:

• During any periods of absence by the EU QPPV initiate from the EU any steps to ensure all activities are prioritized to appropriate AMGEN staff to action upon any request from the agency or relevant proficient authorities.

• Review and comment on EU RMPs periodic/aggregate reports and other relevant documents for scientific oversight and compliance to applicable regulations and law.

• Handle Post Authorisation Safety Study (PASS process) including maintenance of PASS tracker.

• Determines post-authorization safety study (PASS) status in partnership with the Global Safety Officer (GSO).

• Provides guidance for the set-up of a local PSMF for countries in emerging markets.

• Collaborate with the PSMF Compliance and Oversight Lead on the quarterly update and maintenance of the PSMF and act as back-up if needed.

• Coordinate the update of Annex H2.

• Participate in local or global project teams as a subject matter expert in EU regulation and compliance.

• As required represent EU QPPV office internally and externally.

• Author contribute to and review SOPs and other controlled documents relevant to the EU QPPV Office.

• Escalate potential product safety issues or concerns to EU QPPV for input and resolution.

• As appropriate review and perform impact analysis (also solution proposals) on Health Authority proposals for changes in pharmacovigilance regulations and guidelines.

• Provide training on aspects of EU legislation as required.

• Contribute to regular EU QPPV office meetings to ensure information on safety issues regulatory safety issues signals undergoing evaluation and other aspects of the PV system is efficiently communicated across the EU QPPV Office.

• Undertake activities delegated by the EU 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 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.

• Provides operational business support to the EU QPPV Office. Lead initiatives/process improvement opportunities as designated by EU QPPV.

• Partner with EU QPPV Management team to drive and implement strategy goals and initiatives.

• Collaborates cross-functionally with Local Safety Officers and other AMGEN departmental interfaces.

• Proactively identify and resolve upcoming issues within the EU QPPV office and work with stakeholders as needed.

• Provide advice on Patient Support Programs (PSP) when needed to Local Safety Officers.

WIN

WHAT WE EXPECT OF YOU

We are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:

• PharmD or Masters degree in healthcare/science and 6 years of directly related experience.

• Strong knowledge of the EU/UK PV legislation GVP modules and other relevant guidelines.

• Strong background in Pharmacovigilance (PV) including PV best practice in Industry and the Pharmacovigilance System Master File (PSMF).

• Knowledge of safety evaluation and aggregate reports.

• Excellent English written and verbal communication skills.

• Strong organizational and time management abilities.

• Proven collaboration skills with the ability to build relationships and work cross-functionally.

• Ability to work effectively across multiple countries and cultures (preferred).

• Skilled in delivering training (preferred).

THRIVE

WHAT YOU CAN EXPECT OF US

As we work to develop treatments that take care of others so we work to care for our teammates professional and personal growth and well-being.

• Vast opportunities to learn develop and move up and across our global organization.

• Diverse and inclusive community of belonging where colleagues are empowered to bring ideas to the table take risks and act.

• Generous AMGEN Total Rewards Plan comprising healthcare finance wealth and career benefits.

• Flexible work arrangements.

Objects in your future are closer than they appear. Join us.

EQUAL OPPORTUNITY STATEMENT

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.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.