Sunday, May 6, 2018

Pharmacovigilance Specialist, Clinipace Worldwide




Clinipace Worldwide

Pharmacovigilance Specialist
Work LocationSeoul, Korea
Job Code3420
# of openings 1



Job Description

Job Title:  Pharmacovigilance Specialist
Job Location: South Korea, Soeul
Job Overview:
The Pharmacovigilance Specialist (PVS) primary responsibility is SAE case management. This includes but is not limited to: initial case disposition, confirmation of case disposition with Medical Monitor (MM)/Safety Physician PV (SP PV), MM, receipt of adverse event data, data entry, source document data extraction, draft narrative development, follow-up management and reporting according to regulatory requirements.
All activities will be in accordance with Clinipace and/or client SOPs, ICH Guidelines and local regulatory requirements.
Job Duties and Responsibilities:
  • Good working knowledge of medical/drug coding process (MedDRA and WHO drug dictionary)
  • Proficient in processing of safety information of clinical trial, post marketing surveillance and medical devices
  • Perform quality review for expedited cases prior to delivery to the client as needed.
  • Ability to perform reconciliation of SAEs between safety database and clinical database according to defined processes, if needed.
  • Ability to prepare a Draft Safety Safety Management Plan (SMP)
  • Tracking and triage of case information for processing
  • Prioritize incoming AE/SAE/ER information for further processing and confirm receipt, as required.
  • Identify potential 7-Day and 15-Day Alerts
  • Assumes case ownership responsibility for non serious, spontaneous and or serious clinical trial domestic and foreign cases as applicable.
  • Consults with multiple stakeholders (e.g. the sponsor / medical monitor / pharmacovigilance physician) to decide on action and/or additional steps to provide complete narratives to the sponsor.
  • Handling of safety information according to given processes and procedures, by CPWW and/or client SOPs, WPs and Guidelines
  • Perform expedited reporting according to project requirements
  • Possess general working knowledge of PV regulatory frame work
Supervisory Responsibilities:  None
Job Requirements:
  • Education:
    • Degree in life science or nursing/pharmacy qualification or other advanced or equivalent appropriate healthcare or pharmaceutical industry experience or education, e.g. laboratory experience.
    • Medical Documentalist, Medical Documentation Assistant, Nurse with extensive clinical experience or life science degree (e.g. natural scientist with a degree in biology, pharmaceutical medicine of similar speciality) preferred.
  • Experience:
    • At least 1-2 years experience in the tasks and responsibilities performed by a Junior PVS
  • Skills/Competencies:
    • General knowledge of drug therapy, disease states, clinical research
    • Ability to maintain and protect client, patient and corporate confidentiality.
    • Sound working knowledge of regulatory reporting requirements and international regulations (EU, US ,Japan and Asia)
    • Ability to work in an environment of rapidly changing priorities and manage multiple client projects
    • Ability to review medical data from clinical trials and post-marketing experiences, as applicable.
    • Ability to organize and manage work to meet strict timelines
    • Ability to provide exceptional customer service and professional interactions with a varied customer base, as necessary.
    • Use of MS Office products to a competent standard – Word, Excel, PowerPoint
    • Ability to work independently with high reliability and a high sense of responsibility
    • Ability to work as a member of a team and possession of confident communication skills both written and verbal.
    • Ability to communicate in English (both written and verbal)
    • Willingness to provide guidance and training to less experienced staff
    • Willingness for continous on the job training and qualitfications measures
    • Ability to work with careful attention to details
  • Up to  10 % travel, as needed, for project team meetings
  • Client presentations and other professional meetings/conferences as needed
  • Works from home depending on the  arrangement
  • Ability to work remotely
The company will not accept unsolicited resumes from third party vendors.

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