Senior Specialist / Expert - Safety Medical Writer

Job Summary

Position-- Senior Specialist/Expert Safety Medical Writer. Job Location - Bangalore. Your Role. Support Global Patient Safety (GPS) Safety Scientists and Safety Strategy Leads with regards to safety medical writing (SMW) activities. Assist senior staff in developing sections of a wide range of pharmacovigilance documents including but not limited to various Periodic Safety Reports, Signal Assessment Reports, Safety Strategy and Core Benefit-Risk Documents, Risk-Management Plans, Patient Safety Narratives and Health Hazard Reports. Responsible for proofreading, building and populating tables and drafting appendices. Produce high quality, accurate and fit-for purpose documents with clear conclusions. 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. Performs quality control of SMW deliverables for data accuracy, consistency, editing, and ensuring alignment with the processes, templates and regulations. Participate in meetings related to key PV activities. Collaborate cross functionally for continuous improvement of standards and best practices for medical writing.

Responsibilities

• Assist senior staff in developing sections of a wide range of pharmacovigilance documents including but not limited to various Periodic Safety Reports, Signal Assessment Reports, Safety Strategy and Core Benefit-Risk Documents, Risk-Management Plans, Patient Safety Narratives and Health Hazard Reports.
• Responsible for proofreading, building and populating tables and drafting appendices.
• Produce high quality, accurate and fit-for purpose documents with clear conclusions.
• 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.
• Performs quality control of SMW deliverables for data accuracy, consistency, editing, and ensuring alignment with the processes, templates and regulations.
• Participate in meetings related to key PV activities.
• Collaborate cross functionally for continuous improvement of standards and best practices for medical writing.

Requirements

• Graduate degree or equivalent job experience with comprehensive pharmacovigilance knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
• Excellent written and spoken English (including medical terminology) with a familiarity with AMA style guide.
• Profound pharmacovigilance experience (including 5 to 8 years' experience in PSRs) required.
• Demonstrated experience in Periodic Safety Reports of interpretation & presentation of aggregate safety data.
• Strong knowledge of regulations and guidelines (FDA, EMA, ICH, EU GVP, etc.).
• Experience in working in electronic document management systems (EDMS), signal management and benefit-risk assessment is beneficial.
• Proven experience in ability to consistently produce documents of high quality and express complex data in a concise and easy-to-read way.
• Comprehensive experience in working in cross-functional, global teams, across different regions and time zones.
• A flexible attitude with respect to work assignments and new learning; readily adapts to changes.

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