![PERSOLKELLY Malaysia](https://logo.fastjobs.my/companylogo/83/44/00/00/4483_logo.jpg?1=1&t=1635215340)
Global Safety Senior Associate OR Manager
1 week ago
Position : Global Safety Sr Assoc OR Manager (depending on experience and qualification)
Company Industry : Medical
Working Hours : Monday – Friday
Working Mode: Hybrid (3 days WFO, 2 days WFH)
Working Location : Suite 9.01, Level 9, Menara Summit, Persiaran Kewajipan USJ 1, UEP 47600 Subang Jaya, Selangor Malaysia
Working Duration: 7 Months Contract with PERSOLKELLY (possible to extend depends on business needs)
Remuneration : Salary RM7,000 to RM13,000 (based on qualification & education), statutory contribution & leave entitlement
Expected to start: Immediately
WHO CAN APPLY?
OR Bachelor's degree and 5 years of directly related experience
OR Associate's degree and 10 years of directly related experience
OR High school diploma / GED and 12 years of directly related experience
KNOWLEDGE AND SKILLS:
Deep understanding of legislation which applies to safety practices locally
Computer literacy with thorough knowledge of database use
Thorough knowledge of local data privacy requirements
Understanding of relevant medical & safety terminology
Excellent organizational skills
Understanding of team dynamics
KEY ACTIVITIES:
Broader Management and Co-ordination Activities:
Manages local staff and budget resources
Works with Regional safety leads on process improvement initiatives or implementation of legislative changes
Guides training and development activities for local safety staff
Participates in global/ regional /country safety meetings to share best practice
Provides input into cross functional programs, to reflect local requirements
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Strategic Planning Activities:
Activities as Local Safety Responsible Person (For local country or countries):
Acts as safety subject matter expert within the affiliate
Maintains own current knowledge of and compliance with local safety regulations for country or countries under responsibility
Communicates requirements and updates to Safety BPOs and line manager, and ensures local affiliates safety requirements are up to date in GPS SOPs and manuals
Ensures that local safety procedures are documented in line with Amgen /GPS policies and procedures
Collaborates locally with all relevant stakeholders to ensure 24-hour contact ability of the safety function for urgent issues is available
Works with local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors, and distributors, as applicable
Ensures that training on adverse reporting obligations is available for local customer-facing staff and others required by national practice or Company policy, also for relevant contractors, agents or business partners or distributors
Participates in local Crisis Management teams; provides ongoing safety advice
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
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