Vanisha Mattu Email and Phone Number
Diligent and persistent physician with 4 years of experience in Pharmacovigilance handling various aspects of the Industry and I am looking for work with full dedication.Routine safety surveillance for signal detection as Medical Safety Analyst in Empirica tool. Attended Client meetings and presenting forward the new detected signals for IMEs in the meetings which are presented in MSRBs. Expertise in performing medical review of ICSRs (literatures, spontaneous reports and clinical trial cases). Expertise in providing medical inputs and advice to pharmacovigilance scientists on medical aspects in processing of ICSRs. Expertise in providing medical inputs during triage, assessing events for coding and MedDRA coding of events in accordance with “MedDRA Term Selection: Points to Consider”.Expertise in literature reviewing for writing patient narratives for case processing teams. Trained in handling the Enterprise Resource and Planning (ERP) tool. Expertise in medical review of aggregate reporting (PSURs, PBRERs, PADERs, DSURs).Good working knowledge of the Adverse Events safety profile of drugs, Reference Safety Information documents, aggregate reporting conventions and guidelines, clients' procedures and international drug safety regulations including:ICH-GCP guidelines on safety and efficacyGVP ModulesFDA guidelinesMaintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with regulatory timelines.
District Municipality Of Muskoka
View- Website:
- muskoka.on.ca
- Employees:
- 192
-
Personal Support WorkerDistrict Municipality Of Muskoka Jul 2023 - PresentBracebridge, Ontario, Canada
-
Senior Drug Safety PhysicianParexel Apr 2022 - Jul 2022Sahibzada Ajit Singh Nagar, Punjab, India• Expert in Empirica tool for post-market safety surveillance, proficient in signal detection and analysis with 100% compliance.• Proactively contributed to client meetings, providing analysis of 300 assigned products and presenting newly identified signals for evaluations and escalation to Medical Safety Review Boards (MSRBs).• Collaborate effectively with cross-functional teams to ensure seamless operations.• Conducted comprehensive medical review of aggregate reports (PBRER, DSUR, PADER) to ensure compliance with regulations and SOPs.• Proficient in Argus software for meticulous medical review of diverse Individual Case Safety Reports (ICSRs) of Serious Adverse Events and Non-Serious Adverse Events including literature reports, spontaneous reports, patient oriented programs (POPs), and clinical trial cases.• Provided expert medical inputs and guidance to pharmacovigilance scientists during ICSR processing, including accurate MedDRA coding.• Thoroughly review adverse events for completeness, accuracy, and expedited reporting compliance for both marketed and investigational products.• Possess strong knowledge of drug safety profiles, Reference Safety Information, aggregate reporting conventions, and international drug safety regulations (ICH-GCP, GVP, FDA, Health Canada), while maintaining awareness of global regulatory reporting obligations and ensuring compliance with timelines. -
Drug Safety PhysicianParexel Jul 2019 - Jul 2022Sahibzada Ajit Singh Nagar, Punjab, India• Expert in Empirica tool for post-market safety surveillance, proficient in signal detection and analysis with 100% compliance.• Proactively contributed to client meetings, providing analysis of 300 assigned products and presenting newly identified signals for evaluations and escalation to Medical Safety Review Boards (MSRBs).• Collaborate effectively with cross-functional teams to ensure seamless operations.• Conducted comprehensive medical review of aggregate reports (PBRER, DSUR, PADER) to ensure compliance with regulations and SOPs.• Proficient in Argus software for meticulous medical review of diverse Individual Case Safety Reports (ICSRs) of Serious Adverse Events and Non-Serious Adverse Events including literature reports, spontaneous reports, patient oriented programs (POPs), and clinical trial cases.• Provided expert medical inputs and guidance to pharmacovigilance scientists during ICSR processing, including accurate MedDRA coding.• Thoroughly review adverse events for completeness, accuracy, and expedited reporting compliance for both marketed and investigational products.• Possess strong knowledge of drug safety profiles, Reference Safety Information, aggregate reporting conventions, and international drug safety regulations (ICH-GCP, GVP, FDA, Health Canada), while maintaining awareness of global regulatory reporting obligations and ensuring compliance with timelines.
-
Drug Safety PhysicianParexel Jun 2018 - Jan 2019Sahibzada Ajit Singh Nagar, Punjab, India• Extensive expertise in medical review of diverse ICSRs including Serious Adverse Events and Non-serious Adverse Events (literature reports, spontaneous reports, POPs, and clinical trial cases) generated by daily line listings.• Provide expert medical inputs and advice to pharmacovigilance scientists during ICSR processing, including triage, event assessment, and MedDRA coding in accordance with "MedDRA Term Selection: Points to Consider."• Thoroughly review adverse events for completeness, accuracy, and appropriateness, ensuring compliance with expedited reporting requirements.• Possess strong knowledge of drug safety profiles, Reference Safety Information, aggregate reporting conventions, and international drug safety regulations (ICH-GCP, GVP, FDA, Health Canada), while maintaining awareness of global regulatory reporting obligations and ensuring compliance with timelines.
Vanisha Mattu Skills
Vanisha Mattu Education Details
-
Business, Management, Marketing, And Related Support Services -
Health Services/Allied Health/Health Sciences, General
Frequently Asked Questions about Vanisha Mattu
What company does Vanisha Mattu work for?
Vanisha Mattu works for District Municipality Of Muskoka
What is Vanisha Mattu's role at the current company?
Vanisha Mattu's current role is Drug Safety Physician| Pharmacovigilance (ICSRs, Aggregate Reports and Signal Detection)| Clinical Research| Healthcare.
What schools did Vanisha Mattu attend?
Vanisha Mattu attended Canadore College, Adesh University.
What skills is Vanisha Mattu known for?
Vanisha Mattu has skills like Medical Safety Analysis, Clinical Practices, Global Compliance, Clinical Trials, Medical Writing, Signal Detection, Sharepoint, Personal Development, Health And Safety, Icsrs, Empirica, Literature Reviews.
Who are Vanisha Mattu's colleagues?
Vanisha Mattu's colleagues are Chantelle Denstedt, Rick Williams, Ursula Ullrich, Karen A., Joshua Waldon, Catherine Glover, Patricia Lee-Sherlock.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial