Operations Lead, PV
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Job Description
Operations Lead, PV for Sitero collaborating on pharmacovigilance activities and ensuring regulatory compliance. Performing translations and supporting safety information management in compliance with clinical regulations.
Responsibilities:
- 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
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