Principal Medical Writer, Patient Safety

Key Accountabilities:

Note: The below statements describe the general nature and level of the work being performed and are
not an exhaustive list of all responsibilities required for the position. Responsibilities vary as applicable.

Safety Medical Writing and Safety Analysis

Aggregate Safety Reports & Documentation: 

• Independently lead the preparation/update of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions, including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overviews (ACOs), Investigational New Drug Annual Report (INDARs), Semi-Annual Safety Reports (SASRs), Annual Risk- Benefit Evaluation (ARBE) report , Safety statements, Health Hazard Evaluation (HHE), Clinical Overview (CO) and any other ad hoc safety documents, ensuring scientific accuracy, regulatory compliance, and timely delivery. 
• 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 such as but not limited to PBRERs, DSUR etc.). 

• Manage the distribution of final reports to stakeholders, including partners, affiliates, and health authorities, in accordance with agreed timelines, distribution lists, and email templates (as required). 

Safety Analysis & Signal Management:

• 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. Collaborates with cross-functional teams to analyze complex safety data and provide support as part of the study management team. 
• Directs literature review strategies and critically evaluates scientific evidence for inclusion in safety documents.
• Leads safety evaluations for complex molecules and sensitive indications, providing scientific direction that supports clinical strategy and strengthens regulatory positioning through high-quality safety reports and responses. 

Risk Management Plan:

• Leads global RMP and Company Core-RMPs (CC-RMP 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, collaborating with cross-functional teams to ensure scientific and regulatory robustness. 

General Scientific Support: 

• Provides strategic scientific expertise across therapeutic areas, supporting safety documentation and regulatory planning with deep understanding of evolving safety profiles. 
• Drives quality and innovation in documentation standards, process optimization, and cross-functional alignment through proactive planning and oversight. 
• Advises on emerging safety trends, contributing to risk mitigation strategies and representing medical writing in strategic forums and decision-making discussions. 

Client Engagement & Collaborative Communication

• Leads strategic client engagement for complex safety projects, driving discussions, negotiating deliverables, and aligning safety and regulatory strategies with client expectations. 
• Build strong cross-functional relationships, ensuring effective communication, resolving escalations, and enhancing client satisfaction through consistent delivery and collaboration. 

Quality Control & Compliance Management

• Leads quality oversight for complex safety documents, ensuring scientific accuracy, regulatory compliance, and consistency across global submissions. 
• Drives continuous improvement, identifying systemic issues, implementing CAPAs, and establishing KPIs/SLAs to monitor documentation performance. 
• Serves as a SME during audits and inspections, ensuring inspection readiness and adherence to evolving global regulatory standards. 

Strategic Leadership and Team Coordination

• Provides technical leadership and team coordination, ensuring scientific accuracy, regulatory compliance, and timely execution through effective delegation and risk management. 
• Contributes to business growth and operational excellence, supporting proposals, client engagement, and continuous process improvement initiatives. 

Training, Mentorship & Team Development

• Lead advanced training initiatives and mentor team members, building expertise in safety writing, signal detection, and regulatory standards while supporting continuous learning and professional growth. 
• Drives team development and engagement, providing performance coaching, identifying skill gaps, and fostering a collaborative environment that enhances capability and client satisfaction.  

Innovation & Technology

• Supports innovation initiatives by providing scientific expertise to evaluate and implement advanced tools and technologies that enhance safety writing efficiency and align with regulatory and organizational goals. 

Skills:

• 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). 

Knowledge and Experience:                                                                                              

• Prior experience in pharmacovigilance, or related fields is preferred.
• Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.

Education:

• 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.