Position Title:Drug Safety Senior Specialist/Specialist

Position Summary

Be responsible for various types of drug safety case processing, assessment, reporting, review received from various sources to provide high quality safety service delivery to customers. Distribute reports/data onwards to both internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs) and internal guidelines. Apply Knowledge and expertise in the area of regulatory and safety reporting. Serve as principal owner of regulatory and safety reporting deliverables. Provide oversight on projects per requirement.

Key Responsibilities

Provide professional and high quality safety service delivery

  • Receive, triage, review and process safety data from various sources on time, within timeline and quality standards. Perform data entry, code relevant medical terminology, write descript narratives, generate queries pertinent to the case, perform quality control, assist with reconciliation, drive case closure, coordinate translations and ensure reports are sent to the customer within assigned deadlines.
  • Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting safety data.
  • Assess safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with customers or relevant parties to facilitate expedited reporting.
  • Process safety data according to applicable regulations, guidelines, SOPs and project requirements.
  • Contribute knowledge and expertise to or lead assigned deliverable in the field of regulatory reporting.
  • Serve as principal owner of regulatory deliverable and have responsibility for completion of the document in compliance with all applicable service level agreements.
  • Contribute to project management and team result

  • Liaise with customer and relevant parties, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project issues and identify issue resolution..
  • May lead projects to ensure all activities are completed on time and meet quality standards.
  • Mentor less experienced or newer staff members. May provide oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, resource needs, and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.
  • May provide oversight role to impart technical and process information to members of Safety Service Delivery Team.
  • Participate in team meetings and provide regular feedback to Safety Service Delivery Team Managers on project metrics, out of scope work, challenges/issues and successes.
  • Contribute to achievement of team and departmental goals e.g. utilization, productivity metrics.
  • Ensure compliance to regulatory and quality requirements

  • Ensure compliance to dMed high quality standards and works with PV Lead constructively in a matrix framework to achieve project and customer deliverables.
  • Participate in training across PV service offerings. Provide project-specific process training to junior team members, monitors and investigative site personnel, as appropriate.
  • Read and acknowledge all necessary dMed standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.

  • Education and Key Competency Requirement
    Professional Experience & Education Requirement

  • Bachelor’s Degree or educational equivalent in a Scientific or Healthcare discipline
  • Clinical or Medical specialty is a plus
  • At least 3 years’ experience in Pharmacovigilance, drug safety, or related function (such as clinical research, medical, etc.) in pharmaceutical company or CRO

  • Key Competency Requirement

  • Solid experience and knowledge of Pharmacovigilance processes or in particular pharmacovigilance function line; willingness and aptitude to learn new skills across Pharmacovigilance service lines.
  • Good understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs).
  • Proven ability to meet strict deadlines; manage competing priorities.
  • Proven ability to follow instructions/guidelines, work independently and on own initiative.
  • Strong customer orientation.
  • Good understanding of metrics, productivity and initiatives.
  • Excellent attention to detail and accuracy and maintain consistently high quality standards.
  • Excellent written and verbal communication and report writing skills in Chinese and English.
  • Ability to be flexible and receptive to changing process demands.
  • Ability to work effectively on multiple projects simultaneously. Organize own workload and effective time manage of competing priorities.
  • Ability to establish and maintain effective working relationships with coworkers, managers and customers.
  • Apply for the position

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