Safety Medical Writing – Pharmacovigilance
Position Overview
Join the Healthcare team at Merck to contribute to Global Patient Safety (GPS) activities and support the development of high-quality pharmacovigilance documentation.
The role focuses on Safety Medical Writing (SMW), including preparation, review, and quality control of critical safety documents. You will work closely with Safety Scientists, Safety Strategy Leads, and cross-functional global teams to ensure accurate, clear, compliant, and timely delivery of pharmacovigilance documents.
Key Responsibilities
Safety Medical Writing
Support Global Patient Safety Safety Scientists and Safety Strategy Leads with Safety Medical Writing activities.
Assist senior team members in developing sections of a broad range of pharmacovigilance documents.
Contribute to the preparation of Periodic Safety Reports (PSRs).
Support the development of Signal Assessment Reports.
Assist with Safety Strategy and Core Benefit-Risk Documents.
Contribute to Risk Management Plans (RMPs).
Prepare Patient Safety Narratives and Health Hazard Reports.
Draft and develop assigned sections of safety documents while ensuring clarity and scientific accuracy.
Ensure documents contain clear, concise, and scientifically supported conclusions.
Document Preparation and Quality Control
Proofread and edit pharmacovigilance documents for accuracy, clarity, consistency, and readability.
Build and populate tables using relevant safety and aggregate data.
Prepare and draft document appendices.
Perform quality control of Safety Medical Writing deliverables.
Verify data accuracy and consistency throughout documents.
Ensure documents align with approved processes, templates, standards, and regulatory requirements.
Deliver high-quality, fit-for-purpose documents within established timelines.
Safety Data Interpretation and Communication
Interpret and present aggregate safety data within periodic safety reports and other PV documents.
Communicate complex medical, scientific, and technical information clearly and concisely.
Develop documents suitable for both regulatory submissions and internal pharmacovigilance activities.
Ensure conclusions accurately reflect the available safety data and scientific assessment.
Regulatory and Pharmacovigilance Compliance
Maintain comprehensive knowledge of pharmacovigilance principles, processes, and regulations.
Apply relevant regulatory requirements and guidelines when preparing safety documents.
Maintain knowledge of requirements from major regulatory authorities and organizations, including:
FDA
EMA
ICH
EU GVP
Ensure safety writing activities comply with applicable regulatory standards and internal procedures.
Maintain awareness of evolving pharmacovigilance regulations and industry best practices.
Collaboration and Cross-Functional Support
Participate in meetings related to key pharmacovigilance activities.
Collaborate with Safety Scientists, Safety Strategy Leads, and other GPS stakeholders.
Work effectively with global, cross-functional teams across different regions and time zones.
Contribute to the continuous improvement of Safety Medical Writing standards, processes, and best practices.
Support knowledge sharing and effective collaboration across teams.
Required Qualifications and Experience
Graduate degree or equivalent professional experience with comprehensive pharmacovigilance knowledge.
MD, PhD, or an advanced degree in a relevant scientific discipline is preferred.
Approximately 5–8 years of relevant experience in Periodic Safety Reports (PSRs).
Strong experience in pharmacovigilance and safety medical writing.
Demonstrated experience interpreting and presenting aggregate safety data in Periodic Safety Reports.
Strong knowledge of global pharmacovigilance regulations and guidelines.
Excellent written and spoken English, including strong knowledge of medical terminology.
Familiarity with the AMA Style Guide.
Proven ability to produce consistently high-quality, accurate, and well-structured documents.
Ability to communicate complex scientific and safety information in a concise and reader-friendly manner.
Preferred Experience
Experience working with electronic document management systems (EDMS).
Experience with signal management.
Experience with benefit-risk assessment.
Experience supporting global pharmacovigilance activities.
Experience working with cross-functional teams across multiple regions and time zones.
Key Competencies
Strong scientific and medical writing skills.
Excellent attention to detail.
Strong understanding of pharmacovigilance principles.
Ability to interpret complex safety data.
Strong editing and proofreading capabilities.
Excellent written and verbal communication skills.
Ability to manage multiple priorities and meet deadlines.
Strong organizational and project coordination skills.
Ability to adapt to changing assignments and priorities.
Willingness and ability to learn new processes, systems, and regulatory requirements.
Strong collaborative and cross-functional working skills.
About the Healthcare Team
Merck's Healthcare organization is focused on helping create, improve, and prolong lives. The organization develops medicines, intelligent devices, and innovative technologies across therapeutic areas such as Oncology, Neurology, and Fertility.
Its Global Patient Safety teams work across regions and functions to ensure patient safety through effective pharmacovigilance, safety assessment, regulatory compliance, and risk management.
Work Culture
The organization promotes a diverse, inclusive, and flexible working environment that encourages professional development and career advancement. Employees are encouraged to bring different perspectives, collaborate across teams, and contribute to scientific innovation.
Equal Employment Opportunity
The company is committed to providing equal employment opportunities and does not discriminate against qualified applicants or employees based on legally protected characteristics in accordance with applicable laws.
Recruitment Fraud Notice
Candidates should remain cautious of fraudulent job offers from individuals or organizations falsely claiming to represent the company. Applicants should verify recruitment communications through official company channels and avoid sharing sensitive personal or financial information with unauthorized parties.
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Remote, India | Siliguri |Illinois :
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