Pharmacovigilance Specialist PVS (Regular)

Job Description:

Job Title: Pharmacovigilance Specialist PVS (Regular)

Job Location: Seoul (Home-based OR office-based position, any location in South Korea considered)

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 Company 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 safety information of clinical trials, 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 the 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 nonserious, spontaneous, and or serious clinical trial domestic and foreign cases as applicable.
• Consult 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 the PV regulatory framework
  
  

Supervisory Responsibilities:

No supervisory responsibilities

Job Requirements:

• Education
• Degree in life science, 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, or Nurse with extensive clinical experience or life science degree (e.g., a natural scientist with a degree in biology or pharmaceutical medicine of a similar specialty) 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 possess 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 continuous on-the-job training and qualifications measures
• Ability to work with careful attention to details
• Capabilities
• 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.