i have a bachelor’s degree in Dentistry and have completed pg diploma in Clinical research and Regulatory Affairs. i have the ability to work with the physicians in Drug Safety to make sure all medical assessments and reviews are reported appropriately. i have experience in using Databases like argus, medidata rave and inform. i know and have the ability to use proper terminology, i am familiar with the coding dictionaries (MedDRA and whodd) and i have extensive knowledge of Pharmacovigilance regulations and Clinical Trial methodology.
i have the skills and Training needed to monitor and keep track of all mild to serious adverse drug reactions associated with marketed products and with any compounds in Clinical trials. i have the Training and skills to record all data (along with a summary explaining the source and procedures used) into the database accurately and to make updates as new information becomes available.
i have the interpersonal skills to work well as part of a team and the motivation to work independently. i have exceptional research skills with the ability to collect all data surrounding the adverse effects of drugs from various clinical studies, trials and cases.
i have the ability to stay updated on all new safety guidelines and to adhere to the FDA and international rules and regulations at all times. i have the ability to adapt quickly to a changing environment and to switch priorities when necessary. i also have excellent Time Management and organizational skills needed to manage large amounts of data.
Drug Safety OfficerBangalore, Karnataka, India
Since June 2015
i have 5+ years of expereince in the field of Drug Safety.
experienced in entering the safety informtion to the safety Databases.
follow-up of required information.
preparing regulatory reports such as psur.
eperienced in using Databases like argus, medidata rave and inform.
familiar with the international drug regulatory requirements.
fluent in English.
I have 5+ years of expereince in the field of drug safety.
Experienced in entering the safety informtion to the safety databases.
Follow-up of required information.
Preparing regulatory reports such as PSUR.
Eperienced in using databases like Argus, Medidata rave and Inform.
Familiar with the international drug regulatory requirements.
Fluent in English.
Senior drug safety associateBangalore, Karnataka, India
Since June 2015
- management of gobal safety mailbox and managing emails.
- responding to ad hoc requests form clients
- triaging of individual case safety reports (icsr) and coding by using MedDRA.
- triaging of device complaint reports
- case processing includes Data entry and writing narratives according to project specific conventions
- quality check (qc) of the cases and routing the cases to further workflow as required
- generating follow-up queries to trial sites for additional information
- requesting translations and management of translated documents if required
- assisting in dsur preparation
- attending department meetings and preparing minutes of meeting
- processing of legacy cases into the safety database
- involved in development of argus Data entry guidelines
- involved in expedited reporting like submission of Investigator emails
- responding to adhoc requests from clients
- involved in multiple projects at a time
- mentoring and Coaching of new members in the team
- Management of gobal safety mailbox and managing emails.
- Responding to ad hoc requests form clients
- Triaging of individual case safety reports (ICSR) and coding by using medDRA.
- Triaging of device complaint reports
- Case processing includes data entry and writing narratives according to project specific conventions
- Quality check (QC) of the cases and routing the cases to further workflow as required
- Generating follow-up queries to trial sites for additional information
- Requesting translations and management of translated documents if required
- Assisting in DSUR preparation
- Attending department meetings and preparing minutes of meeting
- Processing of legacy cases into the safety database
- Involved in development of Argus data entry guidelines
- Involved in expedited reporting like submission of investigator emails
- Responding to adhoc requests from clients
- Involved in multiple projects at a time
- Mentoring and coaching of new members in the team
Pharmacovigilance associate/Drug Safety
Since June 2015
reporting and triaging of serious Adverse Events used Databases like argus, medidata rave and inform. experienced in writing subject narratives for csr and qc of csr. Reporting and triaging of serious adverse events Used databases like Argus, medidata Rave and Inform. Experienced in writing subject narratives for CSR and QC of CSR.
Drug safety-PharmacovigilanceDecember 2011 --- January 2014
reporting and analysing serous advsrese events (sae's) ,used Databases like argus,medidata rave,inform.
DentistFebruary 2007 --- January 2008
DentistJanuary 2006 --- January 2007
AdaptabilityApproachabilityAssertivenessAttention to detailAnalytical thinkingAuthenticityProactivity
Skills and Expertise
Analytical skills Create SOPs Interact with physiciansAdverse event reportingAssess adverse reactionsAssess subject safety
Diploma in clinical research in Clinical research and regulatory affairs from Manipal University in 2009
BDS in Dentistry from Rajiv Gandhi University of Health Sciences in 2004
BDS in Dentistry from Sri Siddhartha Dental College in 2004