Principal Medical Writer, Patient Safety

• Independently lead the preparation/update of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions
• Serves as an SME for safety reports, developing templates, guiding teams, and creating strategies to address complex regulatory and data presentation challenges
• Facilitate operational coordination, including scheduling and leading meetings, drafting agendas and minutes, tracking action items, and ensuring timely follow-up on open issues to support seamless project execution
• Ensure compliance and quality across aggregate safety reports, performing detailed reviews for factual accuracy and internal consistency across documents
• Manage the distribution of final reports to stakeholders, including partners, affiliates, and health authorities
• Leads advanced safety signal detection and management for key products, integrating diverse data sources and innovative analytical approaches to identify emerging safety concerns
• Provides expert interpretation of complex safety data patterns and trends across product lifecycles
• Leads clinical safety activities for complex molecules, contributing to strategic decisions as part of the global safety team
• Directs literature review strategies and critically evaluates scientific evidence for inclusion in safety documents
• Leads safety evaluations for complex molecules and sensitive indications
• Leads global RMP and Company Core-RMPs development and updates, ensuring alignment with safety profiles, regulatory standards, and strategic goals
• Prepares and reviews regulatory response documents, integrating safety data to support RMP submissions and address authority queries
• Provides strategic input on risk minimization and benefit-risk communication
• Provides strategic scientific expertise across therapeutic areas
• Drives quality and innovation in documentation standards, process optimization, and cross-functional alignment
• Advises on emerging safety trends
• Leads strategic client engagement for complex safety projects
• Build strong cross-functional relationships
• Leads quality oversight for complex safety documents
• Drives continuous improvement
• Serves as a SME during audits and inspections
• Provides technical leadership and team coordination
• Contributes to business growth and operational excellence
• Lead advanced training initiatives and mentor team members
• Drives team development and engagement
• Supports innovation initiatives by providing scientific expertise to evaluate and implement advanced tools and technologies

• Strong analytical and problem-solving abilities, with the capability to independently evaluate complex data and draw meaningful conclusions
• Exceptional communication skills, both verbal and written, including the ability to produce clear, concise, and accurate medical/scientific content
• Excellent interpersonal and collaboration skills, fostering productive relationships with clients, cross-functional teams, and stakeholders
• Effective organizational and prioritization skills, with the ability to manage multiple tasks enthusiastically and maintain attention to detail under tight timelines
• Client-focused mindset, demonstrating flexibility, professionalism, and a proactive approach to meeting client expectations and expanding business opportunities
• Strong negotiation and stakeholder management skills, ensuring alignment of resources, timelines, and deliverables across teams and departments
• Cultural awareness and adaptability, enabling effective communication and collaboration in global, multicultural environments
• Proficient in computer operations and IT tools, with expertise in web-based applications and familiarity with the Windows operating system and Microsoft Office suite (Word, Excel, PowerPoint)
• Prior experience in pharmacovigilance, or related fields is preferred
• Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts
• Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy etc. Or equivalent combination of training and work experience
• Clinical exposure in hospital-based environments is considered advantageous

Clinical exposure in hospital-based environments is considered advantageous