\uc0ac\uc774\ud2b8 \ub9c1\ud06c<\/p>\n
https:\/\/careers.amgen.com\/job\/14943628\/associate-global-safety\/<\/p>\n
<\/p>\n
<\/p>\n
<\/p>\n
<\/p>\n
ASSOCIATE GLOBAL SAFETY<\/p>\n
<\/p>\n
GROUP PURPOSE<\/p>\n
The purpose of this role is to conduct assigned core safety activities for the local affiliate country\/countries, including safety data collection, processing and distribution, under closer supervision, whilst developing expertise in full range. To work with local safety manager to provide specific safety support activities for the local business.<\/p>\n
<\/p>\n
JOB SUMMARY<\/p>\n
This role allows for the conduct of specific core safety activities for safety including data collection, processing and distribution within the relevant local country\/countries, based on appropriate training and assigned roles within the safety database and related systems, under closer supervision of Safety Manager. To maintain compliance with local legislation and Company policies. To assist the Safety Manager in providing the full range of safety activities to support the local business, including safety training, participation in local medical teams providing safety information.<\/p>\n
<\/p>\n
KEY ACTIVITIES<\/p>\n
COLLABORATIVE ACTIVITIES:
\n\u2013 Participates in global\/ regional \/country safety meetings
\n\u2013 Provides input into Safety or cross functional initiatives, if required, to develop best practice<\/p>\n
LOCAL SAFETY AFFILIATE ACTIVITIES (FOR LOCAL COUNTRY OR COUNTRIES)
\n\u2013 Maintains own current knowledge of and compliance with local safety regulations for local country or countries
\n\u2013 Ensures that local safety activities are documented and filed or archived in line with Amgen \/GRAAS policies and procedures
\n-Assists in the training on adverse event reporting obligations for local customer-facing staff and others required by national practice or Company policy
\n\u2013 Assists local Safety team with preparations for audits & inspections of safety operations
\n\u2022 Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
\n\u2022 Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
\n\u2022 Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his\/her supervisor<\/p>\n
CORE SAFETY AFFILIATE RESPONSIBILITIES:
\n\u2013 Performs timely & accurate local processing steps for all adverse events reported to the local affiliate, from all sources, to enable entry into the Global Safety Database
\n\u2013 Assists in safety screening of local medical literature
\n\u2013 Timely submission of all reportable adverse drug reaction reports & the distribution of periodic safety reports or urgent safety communications, as required by local regulations and Amgen procedures
\n\u2013 Facilitates exchange of adverse event information with functional service providers or business partners, in line with specific agreements or procedures
\n\u2013 Supports intake of product complaints, in countries where local safety is designated this activity.<\/p>\n
COMPLIANCE ACTIVITIES:
\n-Works with Safety Manager to maintain required standard of local operating performance and reporting compliance for AE case and periodic safety reports<\/p>\n
-Develops, updates and implements local SOPs to ensure compliance with global PV procedures and national requirements.<\/p>\n
\u2013 Participates in resolution of local issues that occur, through CAPAs and related activities
\n-Ensures local quality assurance measures to maintain inspection readiness of local safety function<\/p>\n
THERAPEUTIC AREA SAFETY SUPPORT:
\n\u2013 Escalates product safety issues to local Safety Manager
\n\u2013 Develops expertise in one or more product or product classes
\n\u2013 Maintains awareness of current prescribing information (e.g. SmPC), investigator brochures and risk management plans to support product safety activities<\/p>\n
With support of Safety Manager and information from Therapeutic Safety Teams:
\n\u2022 Represents Safety in local Medical meetings to discuss product safety issues
\n\u2022 Provides responses to internal and externally sourced safety questions
\n\u2022 Provides product safety training to commercial or medical colleagues
\n\u2022 Assists the Safety Manager to support the local implementation of risk minimisation activities associated with approved risk management plans<\/p>\n
<\/p>\n
KNOWLEDGE AND SKILLS<\/p>\n
\tEvolving working knowledge of Amgen’s policies, procedures and systems
\n \tGrowing understanding of legislation which applies to safety practices locally
\n \tComputer literacy with some knowledge of database use
\n \tAwareness of local data privacy requirements
\n \tUnderstanding of relevant medical & safety terminology
\n \tProactive in seeking assistance in unfamiliar situations<\/p>\n
EDUCATION & EXPERIENCE<\/p>\n
\tBachelor\u2019s degree
\n \tProfessional qualification as a health care professional (doctor, pharmacist, nurse, vet ) or doctoral degree(Preferred)
\n \tExperience in biotech\/pharma industry, clinically based or regulatory agency role(Preferred)<\/p>\n","protected":false},"excerpt":{"rendered":"
\uc0ac\uc774\ud2b8 \ub9c1\ud06c https:\/\/careers.amgen.com\/job\/14943628\/associate-global-safety\/ ASSOCIATE GLOBAL SAFETY GROUP PURPOSE The purpose of this role is to conduct assigned core safety activities for the local affiliate country\/countries, including safety data collection, processing and distribution, under closer supervision, whilst developing expertise in full range. To work with local safety manager to provide specific […]<\/p>\n","protected":false},"author":9113,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[6],"tags":[],"class_list":["post-8007","post","type-post","status-publish","format-standard","hentry","category-free-board"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/posts\/8007","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/users\/9113"}],"replies":[{"embeddable":true,"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/comments?post=8007"}],"version-history":[{"count":0,"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/posts\/8007\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/media?parent=8007"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/categories?post=8007"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.syu.ac.kr\/pharmacy\/wp-json\/wp\/v2\/tags?post=8007"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}