• Prepare and submit PSURs for medical devices in accordance with EUMDR. • Review and analyse safety data from various sources including clinical trials, post-market surveillance, complaints, and adverse event reports. • Collabrate with cross-functional teams including Regulatory Affairs, Clinical Affairs, Quality Assurance and Medical Affairs including tracking MAUDE database to gather relevant safety data for inclusion in PSURs. • Ensure accuracy and completeness of PSURs by conducting thorough data review and verification.• Provide support during regulatory inspections and audits related to PSURs. • Soundful knowledge on Issue Impact Assessment (IIA) and Health Hazard Evaluation (HHE).• Ensure knowledge in risk management and mitigation activities. • Maintain knowledge on MDCG regulations on medical devices.

As a Associate Medical Writer, I have been working on Compilation of CEP, CER, PMCF Plan , PMCF Report and SSCP documents. And gained knowledge and experience in few keyareas like Literature Screening, Summarization and Review. Other than the Job Responsibilities, I am being proactive in writing White Papers, supporting the team to meet timelines with efficient work.

As a Trainee Medical Writer, I have been trained and gained experience in drafting various sections related to CER like Preclinical & Clinical Investigations, Device, Risk, PMS, PMCF, Conclusion and Executive Summary as per EUMDR and MDD guidelines.