Safety Operations Manager

2 weeks ago

India PPD Latin America Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Work Schedule

Environmental Conditions

Job Description

PURPOSE OF THE FUNCTION

  • Oversees operational delivery and staff within Global Patient Safety (GPS) Operations, in accordance with the GPS vision, strategy and regulatory requirements.
  • Interacts with and provides guidance to internal functions and external vendors as required for seamless GPS Operations

ROLES AND RESPONSIBILITIES

  • Oversees and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reporting
  • Coordinates with and supports deliverables with GPS GSL team in relations to case processing
  • Collaborates with other internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) regarding safety related deliverables and processes
  • Communicates with business partners or distributors regarding deliverables related to PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA).
  • Oversees assignment of Safety Specialist tasks, i.e. regarding timely monitoring of GPS communication
  • Proactively identifies issues and areas for improvement and escalates appropriately
  • Proactively engages in the development of new processes and procedures and leads implementation of those
  • Performs all activities in compliance with applicable Controlled Procedures and with global and local regulations as applicable.
  • Performs other tasks as assigned by line manager or Head of GPS

SKILLS AND COMPETENCIES

  • Advanced knowledge of medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan)
  • Proficiency with safety database systems (i.e. Argus) and MedDRA coding
  • Advanced computer skills, including proficiency with Microsoft Office including Excel, Power Point, Visio
  • Communicates complex issues in an understandable, effective and relevant manner
  • Manages and prioritizes a variety of tasks for self and team to meet required deadlines
  • Makes operational decisions with limited supervision and has a good understanding of the overall impact and potential risk
  • Identifies complex problems, raises issues and proposes solutions constructively
  • Proven ability to communicate effectively and collaborate successfully across functions and with vendors
  • Advanced communication in written and spoken English required

EDUCATION, EXPERIENCE AND QUALIFICATIONS

  • Bachelor's /Master's degree (or local equivalent) in nursing, healthcare or other life-science or relevant field
  • Must have JLPT N2 or above level certification
  • At least 7 years of relevant experience in global pharmacovigilance/drug safety (EU&US)
  • Must have worked on PMDA PV related activities
  • Should have hands on experience in managing resource who are working in PV case processing with Japanese Language Proficiency
  • Advanced expertise of global (EU/US) pharmacovigilance requirements and practices
  • Advanced experience with safety database systems (ARGUS preferred) including workflow management
  • Proven experience in interaction with 3rd party vendors
  • Proven experience with the identification of quality issues and evaluation of quality metrics
  • Willing to work in Japan Timezone

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