Sitero

Operations Lead, PV

Sitero

full-time

Posted on:

Location Type: Remote

Location: South Korea

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Job Level

Senior

About the role

  • Operations Lead, PV works collaboratively with Global PV staff, and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance according to the applicable regional and national laws for all medicinal product(s) and territory(ies) for Sitero is responsible.
  • Perform translations and/or quality review of the translations (manual / automated) of the incoming information (safety / non-safety).
  • Perform accurate, complete, and timely translation of safety-relevant information
  • Perform end-to-end case processing and literature surveillance
  • Ensure compliance with international and local guidelines (like GDPR & and applicable data protection laws) into account.
  • Should have access to the reports of suspected adverse reactions and assist in monitoring the regulatory submissions.
  • Perform non-English follow-ups via phone, email etc.
  • Support in preparation of submission packages (local forms in local languages) for local Health Authority case submissions.
  • Keep abreast of national pharmacovigilance and regulatory affairs regulations.
  • Receive and handle medical information enquiries from patients and health care professionals.
  • Must be contactable during business hours.
  • Demonstrate knowledge and ensure compliance with current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), Sitero SOPs and quality standards.
  • Stay current with international pharmacovigilance requirements and guidelines.
  • Foster an environment of collaboration, team building, and continuous improvement.

Requirements

  • Fluent in Korean language (native or near-native in target language)
  • Excellent written communication skills
  • Trained in pharmacovigilance terminology
  • Documented PV training (e.g. SOP training, GVP awareness)
  • Understanding of medical terminology (medical degree not required, but experience is)
  • Preference for a minimum 2 years relevant medical, scientific/clinical, or pharmaceutical experience
  • Competent knowledge of good pharmacovigilance practices
  • Competent knowledge of US and EU pharmacovigilance regulatory requirements
  • A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways
  • Experience in the review of relevant safety information from all sources and analysis of safety data
  • Knowledge of global clinical and post-marketing safety regulations, guidance documents, and reporting processes
  • Expertise with MedDRA, XEVMPD coding and safety database systems
  • Exhibit excellent organizational, presentation and communication (verbal and written) skills
Benefits
  • Availability during local business hours
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
pharmacovigilancetranslationscase processingliterature surveillancemedical terminologygood pharmacovigilance practicessafety data analysisMedDRA codingXEVMPD codingsafety database systems
Soft Skills
written communicationorganizational skillspresentation skillsverbal communicationcollaborationteam buildingcontinuous improvementproblem-solving
Certifications
documented PV trainingSOP trainingGVP awareness