Manvi Goel
Healthcare Professional | Pharmacovigialnce Associate | Patient Safety Associate | Medical Writing | Regulatory affairs | Dentist | Ex- Fortis Hospital | Medical Administration
- Role
- Drug Safety Associate at Parexel
- Location
- Chandigarh, IN
- LinkedIn followers
- 500 followers
About Manvi Goel
As a Drug Safety Associate with almost 2 years of experience in pharmacovigilance, I…
Experience
Drug Safety Associate
Mar 2024 — Present · Chandigarh, IN
Triage and process Individual Case Safety Reports (ICSRs), ensuring timely and accurate submissions toregulatory authorities according to global safety regulations, including ICH, FDA, and CIOMS guidelines. Manage the registration of ICSRs in safety databases, conducting thorough duplicate searches and efficientlyresolving potential cases to maintain data integrity. Conduct data validation by cross-checking with source documentation, ensuring compliance with globalsafety standards. Provide medical safety insights by monitoring post-marketing safety data, analyzing trends, and identifyingsafety signals related to assigned drugs. Collaborate with cross-functional teams to ensure accurate reporting and adherence to organizational andregulatory requirements. Leverage strong knowledge of international drug safety regulations to assist with regulatory submissions,improving response timelines and quality of documentation.
Education
Convent of Jesus and Mary, Ambala
Class 10th
Panjab University, Chandigarh
Bachelor of Dental Surgery
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