Merck Group Hiring Expert Safety Medical Writer (aggregate reports)

Merck Group Hiring Expert Safety Medical Writer (aggregate reports)

25 April, 2022

Job description:

BANGALORE IS LOOKING FOR

Expert Safety Medical Writer

(aggregate reports- PBRER, PADER, RMP, SIGNAL, PSUR, DSUR etc.)

Your Role:

  • Support Global Patient Safety (GPS) Safety Scientists and Safety Strategy Leads with regards to safety medical writing (SMW) activities.
  • Author 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.
  • Author responses to Health Authorities queries (ad-hoc queries, queries following submission of PBRER/PSUR, such as PRAC inquiries, etc.).
  • 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.
  • Review (both self- and peer) of SMW deliverables for data accuracy, consistency, 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 (5 to 9 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 signal management, benefit-risk assessment, literature surveillance 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 through this Link

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