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Expert Safety Medical Writer (aggregate reports)
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Description
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Support Global Patient Safety (GPS) Safety Scientists and Safety Strategy Leads with regards to safety medical writing (SMW) activities.
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Author a wide range of pharmacovigilance documents including but not limited to various Periodic Safety Reports, Signal Evaluation Reports, Safety Strategy and Core Benefit-Risk Documents, Risk-Management Plans, Patient Safety Narratives and Health Hazard Reports.
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Author responses to Health Authorities queries (ad-hoc queries, queries following submission of PBRER/PSUR, such as PRAC inquiries, etc.).
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Effectively and clearly communicate technical, medical, and scientific information in critical submission and internal PV documents in order to deliver high quality reports within the specified timelines.
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Review (both self- and peer) of SMW deliverables for data accuracy, consistency, and ensuring alignment with the processes, templates and regulations.
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Participate in meetings related to key PV activities.
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Collaborate cross functionally for continuous improvement of standards and best practices for medical writing.
Responsibilities
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Graduate degree or equivalent job experience with comprehensive pharmacovigilance knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
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Excellent written and spoken English (including medical terminology) with a familiarity with AMA style guide.
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Profound pharmacovigilance experience (5 to 9 years’ experience in drug/patient safety) required.
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Demonstrated experience in Periodic Safety Reports of interpretation & presentation of aggregate safety data.
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Strong knowledge of regulations and guidelines (FDA, EMA, ICH, EU GVP, etc.).
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Experience in signal management, benefit-risk assessment, literature surveillance is beneficial.
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Proven experience in ability to consistently produce documents of high quality and express complex data in a concise and easy-to-read way.
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Comprehensive experience in working in cross-functional, global teams, across different regions and time zones.
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A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
Hard Skills
- Data Management
- Cross-functional collaboration
- Advanced language knowledge
- Advanced writing skills
- Proofreading and editing skills
- Audio translating experience
- Document interpretation
- Simultaneous translations experience
Soft Skills
- Communication
- Adaptability
- Team player
- Skilled Collaborator
- Flexible
