Sitero

Operations Lead, PV

Sitero

full-time

Posted on:

Location Type: Remote

Location: China

Visit company website

Explore more

✨ AI Apply
Apply

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.
  • 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).
  • 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.

Requirements

  • Fluent in Chinese 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.
  • 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
pharmacovigilancetranslationcase processingliterature surveillancesafety data analysisMedDRA codingXEVMPD codingsafety database systemsgood pharmacovigilance practicesmedical terminology
Soft Skills
written communicationorganizational skillspresentation skillsverbal communication
Certifications
documented PV trainingSOP trainingGVP awareness