PHARMAFull-time
Senior Specialist / Expert - Safety Medical Writer
By Admin · Medical & Scientific Writing
BANGALORE (IN)ONSITEPOSTED: 9/11/2026
PHARMAFull-time
HIRING ORGANIZATIONMERCK KGAAPharmaceuticals and Life Sciences
ROLE OVERVIEW
Support Global Patient Safety teams by producing high-quality pharmacovigilance medical-writing deliverables, including periodic safety reports, signal assessments, benefit-risk documents, risk-management plans, patient safety narratives, and health hazard reports.
ROLE DEFINITION & RESPONSIBILITIES
- •Support Global Patient Safety Safety Scientists and Safety Strategy Leads with safety medical writing activities
- •Assist in developing Periodic Safety Reports, Signal Assessment Reports, Safety Strategy and Core Benefit-Risk Documents, Risk-Management Plans, Patient Safety Narratives, and Health Hazard Reports
- •Proofread documents and build and populate tables and appendices
- •Produce accurate, high-quality documents with clear conclusions
- •Communicate technical, medical, and scientific information in critical PV documents within timelines
- •Perform quality control for data accuracy, consistency, editing, templates, processes, and regulatory alignment
- •Participate in meetings related to key pharmacovigilance activities
- •Collaborate cross-functionally to improve standards and medical-writing best practices
Reporting Hierarchy: Reports to Global Patient Safety leadership and collaborates with Safety Scientists, Safety Strategy Leads, and cross-functional global teams; Exact reporting manager and team size are not specified in the posting
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Graduate degree or equivalent job experience with comprehensive pharmacovigilance knowledge
- MD, PhD, or advanced science degree
- Excellent written and spoken English including medical terminology
- 5-8 years of experience in Periodic Safety Reports
- Experience interpreting and presenting aggregate safety data
- Strong knowledge of FDA, EMA, ICH, and EU GVP regulations
- Experience working in global cross-functional teams
PREFERRED QUALIFICATIONS
- •Experience with electronic document management systems
- •Experience in signal management
- •Experience with benefit-risk assessment
- •Familiarity with AMA style guide
- •Experience working across different regions and time zones
REQUIRED VERIFIED SKILLS
Pharmacovigilance
safety medical writing
Periodic Safety Reports
aggregate safety data
signal assessment
benefit-risk assessment
Risk-Management Plans
patient safety narratives
Health Hazard Reports
FDA regulations
EMA regulations
ICH guidelines
EU GVP
medical terminology
medical writing
quality control
proofreading
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Benefits not explicitly specified in the provided posting; company highlights opportunities for personal development, career advancement, inclusion, flexibility, and belonging.
No salary range or bonus/equity information is disclosed in the supplied job posting. Compensation should be confirmed directly with Merck KGaA and will depend on experience, pharmacovigilance expertise, medical-writing capability, and seniority.
ORGANIZATION CONTEXT & CULTURE
Merck KGaA operates across Healthcare, Life Science, and Electronics, developing medicines, healthcare technologies, scientific solutions, and other innovations. Its Healthcare organization focuses on improving and prolonging lives through therapeutic and technology-based solutions.
TEAM SIZE: 60,000+ employees
INDUSTRY: Pharmaceuticals and Life Sciences
Culture: Merck emphasizes scientific innovation, curiosity, inclusion, belonging, flexibility, personal development, and collaboration across global teams.
EXPECTED CAREER ROADMAP
The role can progress toward senior safety medical-writing leadership, safety strategy, pharmacovigilance leadership, or broader Global Patient Safety management positions, depending on performance and expertise.
APPLICATION ADVISORY
Emphasize 5-8 years of Periodic Safety Report experience; Highlight experience interpreting and presenting aggregate safety data; Demonstrate knowledge of FDA, EMA, ICH, and EU GVP requirements; Showcase examples of safety medical-writing deliverables; Mention signal management, benefit-risk assessment, or EDMS experience; Highlight global cross-functional collaboration and strong medical/scientific English writing.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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