Drug safety Associate, Publishing Specialist

Veronica Dasari

C: 872-***-****, E: ac0tgs@r.postjobfree.com

Objective:

Regulatory Affairs professional with strong academic background in medical sciences along with 2 years of experience in Clinical Research Industry for drugs and my educational background as a dentist. My Profession helped me in a thorough Knowledge in Pharmacovigilance/Drug Safety (PV), Safety Medical Writing (PSUR /PBRER /AR), Regulatory Submissions and a Process Trainer exposure.

Summary & Skills:

With an overall experience of 2 years, I excelled in Drug safety and Regulatory roles starting from case initiation, Triage, Data entry, narrative writing, Expectedness & Causality Assessment, Quality reviewing and Regulatory Publishing

Displayed a thorough knowledge on ICSR case processing, Processing of serious, non-serious cases, Clinical trial cases and literature cases

Worked on Databases namely Arisg, Argus, MHRA & EVWEB

Well Versed with Medical terminology, MEDRA, WHO dictionary

Expert user of various reference information’s such as CCDS, USPI, SMPC & IB.

Experience in working with CRO/Vendor that handles case processing activities and safety medical writing (PBRER/PSUR/DSUR).

Thorough understanding of CFR guidelines, ISO 9001, ISO 13485, Labelling directives, Quality regulations (21CFR820)

Well Versed with Canadian, Australian and European Medical Device Regulations

Well versed with medical devices regulations & development De Novo Submissions, Post Marketing Surveillance Studies.

Regulatory knowledge of Drug Development Process

In-depth Knowledge on GVP modules, CGMP Regulations, ICH guidelines, Meddev

Well versed with Submissions in IND, NDA, BLA, PMA, IDE, 510(k) submissions

Work Experience:

Regulatory Submissions Specialist, June 2011 to Jun 2013

Synowledge PV Services, Bangalore, India.

Client: Merck

Prioritize & manage tasks associated with Regulatory Submissions including word

processing, technical preparation, performing quality audits to meet FDA and ICH guidelines

Support the compilation, development, publishing, submission and maintenance of regulatory filings under the direction of RA submission manager.

Identified the need of submissions by case assessment and reporting requirements as per country (Reg authority, ECs and Sites, cross reporting).

Prepared the cover letters/country specific templates and submission packages.

Electronic reporting: Tested the database with health authorities & Imported the case in EVWEB & checked the validation rules for each authority where the case is being submitted.

Identified the need of translation and coordinated with the vendor for translation.

Conducted the data base Search for AOSE

Drug Safety Associate:

Prepared/ updated Sops for any new developing process related to the project & Quality Improvement Plans

Accomplished in case intake, duplicate check, registration, processed incoming cases with full data entry, reviewed data entered for accuracy, ensured to meet applicable timelines

Processed (Full data entry with narrative writing) with medical coding, reviewed and submitted serious cases, non-serious cases, pregnancy cases, literature cases and clinical trial cases

Followed up with sites regarding outstanding queries & on reconciliation of discrepancy

Performed PBRER writing and PV case processing and prepared template as per EMEA guidelines to train new hires

Trained new hires on PV definitions/Regulatory timelines, Process workflow and their roles and responsibilities, SOP’s for inclusion/exclusion criteria for data basing a case, case deactivation, duplicate search, special case scenario.

Trained new hires on GVP modules, adverse event reporting or medical device reporting

Evaluate incoming product events to determine MDR and Vigilance reporting eligibility

Conducted regular huddles and quality related feedback to the team.

Quality Reviewer:

Reviewed and verified incident reports for completeness and consistency

Contributed to overall management & oversight of the quality system for PV & Regulatory activities

Coordinated and drive lifecycle management of PV and Regulatory processes and compliance

Developed reporting tools, methodologies and technology in support of quality and compliance monitoring, analysis and reporting

Validated Adverse event report form against standard Company SOPs to determine incident report and action

Ensure the documentation of processed and received reports as per Good Documentation practices

Ensure inspection readiness at all time

Certifications:

Post-graduate diploma in clinical research Jun 2013 to 2016

Evaluation Certifications by FDA:

1.FDA’s Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond

2.FDA Overview of Biosimilar Products

3.FDA eCTD Overview and Submission

4.FDA Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND

Education:

Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical, Dec 2017

Northeastern University, Boston, MA.

Post-Graduation Diploma in Clinical Research, Jun 2011

Clinotek India, Bangalore, India.

Bachelors of Science in Dentistry, Oct 2010

Mamatha Dental College, Khammam, India.

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