Senior Medical Writer, Patient Safety in India at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Medical Writer, Patient Safety in India.

This role sits at the intersection of scientific writing, pharmacovigilance, and global regulatory compliance, supporting the development of high-impact safety documentation for pharmaceutical products across multiple regions. You will lead the preparation of complex aggregate safety reports and risk management documents that directly inform regulatory decisions and benefit-risk assessments. The position requires deep scientific expertise and the ability to translate complex safety data into clear, compliant, and strategic regulatory submissions. You will collaborate closely with cross-functional global teams, including safety, regulatory, and clinical experts, to ensure consistency and scientific rigor across all deliverables. The role also involves leading signal detection and safety analysis activities, contributing to proactive risk identification and mitigation strategies. In addition, you will engage directly with clients and health authorities, acting as a key advisor on safety documentation strategy. This is a highly visible, senior-level role with strong influence on global patient safety outcomes.

Lead the development, review, and strategic oversight of complex patient safety documentation and regulatory safety deliverables, ensuring scientific accuracy, compliance, and alignment with global pharmacovigilance requirements.

• Lead preparation of aggregate safety reports including PSURs, PBRERs, DSURs, PADERs, IND annual reports, and other global safety documentation.
• Develop strategic approaches for complex safety submissions, ensuring clarity, scientific rigor, and regulatory impact.
• Review and approve high-complexity safety documents and coordinate multi-document regulatory submission packages.
• Design and execute advanced signal detection and safety analysis strategies across diverse datasets and therapeutic areas.
• Prepare and evaluate risk management plans (RMPs/CC-RMPs), ensuring alignment with global regulatory expectations.
• Develop responses to health authority queries and support regulatory interactions related to safety documentation.
• Lead literature reviews, safety evaluations, and benefit-risk assessments to support regulatory and clinical decisions.
• Serve as a key scientific advisor in cross-functional and client-facing safety strategy discussions.
• Ensure audit readiness, quality compliance, and adherence to global pharmacovigilance standards and SOPs.
• Mentor and guide junior team members while contributing to training, process improvement, and knowledge sharing initiatives.

Strong experience in pharmacovigilance and medical writing, with deep expertise in global safety reporting, regulatory requirements, and benefit-risk assessment in the pharmaceutical or life sciences industry.

• Degree in Life Sciences, Pharmacy, Biomedical Sciences, or related field; advanced qualifications preferred.
• Extensive experience in medical writing and pharmacovigilance or drug safety-related roles.
• Strong understanding of global pharmacovigilance regulations and safety reporting standards.
• Proven experience preparing PSURs, DSURs, PBRERs, RMPs, and other aggregate safety reports.
• Expertise in signal detection, safety analysis, and benefit-risk evaluation.
• Strong scientific writing skills with the ability to translate complex data into clear regulatory documentation.
• Experience working in global, cross-functional, and client-facing environments.
• Proficiency in MS Office and familiarity with pharmacovigilance systems and tools (e.g., MedDRA, WHO-DD).
• Excellent analytical, organizational, and time management skills with ability to manage multiple priorities.
• Strong communication and leadership abilities with experience mentoring or guiding teams.

• Competitive compensation aligned with senior scientific expertise
• Health and wellness benefits package
• Paid time off and flexible work arrangements
• Opportunity to work on global pharmacovigilance and patient safety programs
• Strong exposure to international regulatory authorities and client engagement
• Career development and continuous learning in drug safety and medical writing
• Collaborative, science-driven, and mission-oriented work environment
• Opportunities for leadership, mentoring, and technical innovation