Job title: COMW-0, safety medical writer
Company: Merck Group
Job description: A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the wo
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. Position- Expert -Safety Medical Writer Job Location – Electronic City – 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 ofa 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. Responsible for proofreading, building and populating tables anddrafting 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 Who youare: 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 (3to 5years’ experience in drug/patient safety) 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 managment systems (EDMS), signal management andbenefit-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. What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life! Curious? Apply and find more information at
Expected salary:
Location: Bangalore, Karnataka
Job date: Sat, 20 Aug 2022 22:19:10 GMT
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