Pj Manohar
Sr Associate III/Medical Safety Writer/Medical Devices/Aggregate Safety Reports (PBRER/DSUR/PSUR/LM Reports/PADER/SUSAR Reports), Regulatory Writing
- Role
- Medical Safety Writer at Alcon
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Pj Manohar
Experienced in Pharmacovigilance, and safety reporting, I specialize in managing global…
Experience
Medical Safety Writer
May 2023 — Present · Bengaluru, IN
I have spearheaded regulatory submissions for the Ophthalmology portfolio, including PSURs (EU), Canada Summary Reports, Peru PMSRs, China PRER, and India PSURs. I have optimized the use of tools like Tableau, Cognos, and PowerApps for efficient extraction and analysis of safety data. I have collaborated with the US team to ensure the timely submission of all required reports, facilitating seamless communication and meeting deadlines across regions.I have supported the development of formatting guidelines that enhance uniformity across reports, ensuring consistency and quality. I have also supported TUV audits, which are crucial for medical device license renewals, contributing to regulatory compliance and certification processes.
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