Poonam Kumari

- Authored and reviewed a range of safety reports (PBRERs, PADERs, DSURs).
- Collaborated with clinical teams to resolve narrative and safety-related queries.
- Handled regulatory documentation in line with ICH, FDA, and client SOPs.

• Client: Sanofi Pasteur
• Suggested ideas for new projects to current clients that aligned with and advanced business goals.
• Mentored junior medical writers, promoting professional growth and fostering a collaborative work environment.
• Supported successful product launches through timely completion of essential regulatory documents required for approval processes.

- Composed clinical narratives and safety reports ensuring regulatory compliance.

- Conducted data validation and reviewed CSR narratives for submission quality.

- Participated in signal assessments and mentored junior team members.

• Client: Sanofi Pasteur

• Reviewed and proofread medical content for accuracy, clarity, and consistency.
• Ensured adherence to academic and regulatory language standards.
• Improved document accuracy by meticulously proofreading and editing various types of content.
• Maximized document quality by suggesting revisions for awkward phrasing or unclear language.
• Checked and corrected grammatical and spelling errors in diverse documents.
• Revised work to identify missed mistakes before completing assigned assignments.