Senior Medical Writer, Patient Safety

Job Description:

Responsibilities

• Aggregate Safety Reports & Documentation:
• Leads the preparation 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), 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)
• Develops strategic approaches for challenging safety submissions, incorporating innovative data presentation techniques to enhance clarity and regulatory impact.
• Reviews and approves high-complexity safety documents, ensuring scientific accuracy, regulatory compliance, and alignment with product strategy.
• Coordinates multi-document submissions, ensuring consistency and integration across safety documentation packages.
• Provides expert guidance on evolving global regulatory requirements and advises on their implications for safety documentation.
• Manages meeting logistics including scheduling, agenda drafting, minute preparation, and tracking of action items, ensuring timely follow-up and resolution of open issues.
• Safety Analysis & Signal Management:
• Designs and implements advanced signal detection plans tailored to specific product profiles and diverse data sources.
• Leads signal detection for priority products by conducting expert-level analyses to uncover subtle safety signals and complex data patterns.
• Develops robust literature review strategies and critically evaluates complex scientific evidence or inclusion in PSRs, drug safety reports, and RMPs.
• Supports clinical safety and ad-hoc safety activities for complex molecules, contributing to strategic safety evaluations.
• Authors and reviews high-priority signal assessment reports and health authority response documents, resolves data challenges, and enhances decision-making through expert analysis and innovative visualizations.
• Risk Management Plan:
• Leads the preparation, updating, and integration of Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs) across multiple regulatory regions and product types, ensuring alignment with evolving safety profiles and strategic objectives.
• Prepares and handles reviews of health authority response documents, incorporating safety data and regulatory insights to address queries and support submissions of RMPs.
• Oversees Reference member state (RMS) updates, ensuring consistency with client conventions, global regulatory expectations, and internal SOPs.
• Provides strategic input on risk minimization measures and benefit-risk communication, tailoring content to diverse regulatory audiences.
• Collaborates with cross-functional teams to ensure RMPs are scientifically robust, compliant, and aligned with the overall safety strategy. 

Qualification & Experience    

• 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. 
• Demonstrates advanced analytical thinking and problem-solving skills to interpret complex safety data and derive meaningful conclusions to support benefit-risk assessments.
• Possesses strong scientific writing and communication capabilities, ensuring the production of clear, accurate, and regulatory-compliant documents.
• Strong capability to lead and collaborate across cross-functional, global teams and build trusted client relationships.
• Excels in organizational and time management, with the ability to prioritize tasks, manage multiple high-impact projects, and consistently meet deadlines.
• Proficient in medical writing tools and MS Office applications, with working knowledge of pharmacovigilance databases and coding dictionaries such as MedDRA and WHO-DD.
• Proactive in adopting new technologies, driving process improvements, and applying innovative approaches to safety documentation.
• 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.