Group Purpose
This role demonstrates a good working knowledge of Amgen's policies, procedures and systems and practical understanding of legislation which applies to safety practices locally. Effective operation performance is based on ability to conduct core operational activities based on competent knowledge of safety terminology, database use and tools needed to handle and submit individual and period safety reports. The role also requires the ability to develop a broad understanding of how local safety supports both Amgen Global Patient Safety and the local business.
Job Summary
- To conduct core safety activities including data collection, processing, distribution and regulatory submission within the relevant local country/countries, based on appropriate training and assigned roles within the safety database and related systems.
- To maintain compliance with local legislation and Company policies. To assist Safety Manager to provide full range of safety activities to support the local business, including safety training and participation in local medical teams providing safety expertise and information. The ability to identify, prioritise and escalate safety issues is also very important.
Key Activities
- Participates in global/ regional/ country safety meetings
- Provides input into Safety or cross functional initiatives, if required, to share and develop best practice
Local Safety Affiliate Activities (For local country or countries)
- Maintains own current knowledge of and compliance with local safety regulations for local country or countries
- Works with Safety Manager to keep local affiliate safety requirements up to date in GRAAS SOPs and manuals, and reporting requirements.
- Ensures that local safety activities are documented and filed or archived in line with Amgen /GRAAS policies and procedures
- Assists in the training on adverse event reporting obligations for local customer-facing staff and others required by national practice or Company policy, also for relevant contractors, agents, business partners or distributors
- Assists local Safety team during conduct of audits & inspections of safety operations and other PV interactions with local Regulators
- Assists Safety Manager and local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors and distributors, as applicable
- Timely & accurate capture, routing, translation and follow up of adverse events reported in the local country(ries) for inclusion in the Global Safety database
- Assists with timely submission of all reportable adverse event reports
- Assists with distribution of periodic safety reports for local and/or regional needs
- Assists with the dissemination of urgent safety communications, DHPCs and DILs required by Amgen decisions or Regulatory Agency demands, according to local requirements
- Assists in safety screening of local medical literature
- Facilitates exchange of adverse event information with functional service providers, distributors or business partners, in line with specific agreements or procedures
- Assists intake of product complaints in countries where local safety department is designated to support product quality department with this activity..
- Works with Safety Manager to maintain required standard of local operating performance and reporting compliance for AE case and periodic safety reports
- Participates in resolution of local issues that occur, through CAPAs and related activities
- Ensures local quality assurance measures to maintain inspection readiness of local safety function
- May assist Safety Manager and local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors and distributors, as applicable
- May assist in safety review of protocols of local interventional, non-interventional studies (NIS) and independently sponsored studies to ensure safety monitoring and data collection are appropriately addressed.
- May assist in local safety review of plans / vendor contracts of local market research studies and patient support programmes to ensure safety contract language, training, monitoring and data collection are appropriately addressed
- May assist in review of local Amgen sponsored websites/social media projects, if used, to ensure appropriate compliance measures are implemented, for capture of potential adverse events received
- May assist in tracking dissemination of DHCPS, DILs and risk minimisation measures, such as physician education booklets
- 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
Therapeutic Area Safety Support
- Escalates product safety issues to local Safety Manager
- Develops expertise in one or more product or product classes
- Maintains awareness of current prescribing information (eg. SmPC), investigator brochures and risk management plans to support product safety activities
- May represent Safety in local Medical meetings to discuss product safety issues
- Uses specific product expertise to contribute to responses for internal and externally sourced safety questions collaborating with Regulatory or Medical Information, for topics delegated by Safety Manager
- Assists in providing product safety training to commercial or medical colleagues and if applicable, to business partners, contract providers and distributors
- Assists Safety Manager in local implementation of risk minimisation activities associated with approved risk management plans
- Assists Safety Manager to build awareness of product safety issues within local market or clinical research environment and provide feedback to stakeholders as requested by Safety Manager.
Knowledge and Skills
- Good working knowledge of Amgen's policies, procedures and systems
- Practical understanding of legislation which applies to safety practices locally
- Computer literacy with competent knowledge of database use
- Knowledge of local data privacy requirements
- Understanding of relevant medical & safety terminology
- Ability to identify, prioritise and escalate safety issues
- Problem solving abilities
- Confident handling of core operational safety activities, when trained
Education & Experience (Basic)
Master’s degree
OR
Bachelor’s degree and 2 years of directly related experience
OR
Associate’s degree and 6 years of directly related experience
OR
High school diploma / GED and 8 years of directly related experience
Location
Beijing
Education & Experience (Preferred)
- Professional qualification as a health care professional (doctor, pharmacist, nurse, vet ) or doctoral degree
- Experience in biotech/pharma industry - clinically based or regulatory agency role
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.
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