Merck Bangalore is Hiring Expert – Safety Medical Writer (Pharmacovigilance)

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 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

Who you are:

• 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 (3 to 5 years’ 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 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.

Apply HERE