Sitero

Manager, PV Operations

Sitero

full-time

Posted on:

Location Type: Remote

Location: Japan

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About the role

  • Local PV Officer works collaboratively with Global PV staff, and cross-functional colleagues/teams for pharmacovigilance activities.
  • Ensure regulatory compliance according to applicable regional and national laws.
  • Perform translations and/or quality review of incoming safety/non-safety information.
  • Conduct non-English follow-ups for gathering safety information.
  • Support in preparation of submission packages 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.

Requirements

  • Fluent in source and target 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.
  • 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.
  • Excellent organizational, presentation and communication skills.
Benefits
  • Health insurance
  • Competitive salary
  • Professional development budget
Applicant Tracking System Keywords

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

Hard Skills & Tools
pharmacovigilancemedical terminologysafety data analysisMedDRA codingXEVMPD codingsafety database systemsgood pharmacovigilance practicesregulatory compliancesubmission package preparationsafety information review
Soft Skills
written communicationorganizational skillspresentation skillscollaborationattention to detailinterpersonal skillsquality reviewlanguage proficiency
Certifications
PV trainingSOP trainingGVP awareness