Senior Medical Writer, Patient Safety

This is a fully remote position, open to applicants in India.

📋 Description

• Oversees the creation of intricate scheduled and unscheduled aggregate safety reports across various product categories and regulatory jurisdictions.

• Formulates strategic methodologies for complex safety submissions.

• Evaluates and endorses high-complexity safety documentation.

• Coordinates meeting logistics, including scheduling, drafting agendas, and preparing minutes.

• Develops and executes advanced signal detection strategies customized to particular product profiles.

• Directs signal detection for priority products through expert-level analyses.

• Composes and reviews high-priority signal assessment reports and documents for health authority responses.

• Prepares and manages the review of documents responding to health authorities.

• Collaborates with cross-functional teams to ensure Risk Management Plans (RMPs) are scientifically sound and compliant.

• Exhibits extensive knowledge of safety profiles across a diverse range of therapeutic areas.

⛳️ Requirements

• Previous experience in pharmacovigilance or related fields is preferred.

• Demonstrates a strong 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—or an equivalent combination of training and work experience.

• Clinical exposure in hospital-based settings is viewed as advantageous.

🏝️ Benefits

• Health insurance

• Flexible work arrangements

• Professional development opportunities