Operations Lead, PV
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Job Description
Operations Lead overseeing pharmacovigilance activities for Sitero based in Beijing, China. Collaborating with Global PV staff and ensuring regulatory compliance.
Responsibilities:
- 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
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