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

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

23 August, 2022

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

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