Manager, PV Operations
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Job Description
Local PV Officer collaborating with Global teams for pharmacovigilance activities and regulatory compliance. Performing translations and managing safety information while ensuring compliance with regulations.
Responsibilities:
- 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
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