Require Safety Medical Writer at Merck Limited

Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967. The Company operates both its Pharmaceuticals and Chemicals businesses in the country. Merck was also the first Merck Group Company to go public in the year 1981. The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd.

Post : Safety Medical Writer

Job Description :
• 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 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 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

Candidate Profile :
• 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 7 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.

Additional Information
Experience : 5 to 7 years
Qualification : Graduate degree or equivalent
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Job Requisition ID : 268606
End Date : 31st October, 2023