Medical Device

Summary of Expertise:

* ***** * ****** ********** in Pharmacovigilance of clinical/Marketed drugs and 1 year 6 months experience in Regulatory Affairs of Medical devices.

Good sound of knowledge of FDA’s, MHRA’S, USFDA organization and its regulatory compliance processes.

Collect the information about safety and effectiveness of the drug approved in the NDA.

Submitted applications for NDA’s and ANDA’s. according to ICH guidelines.

Knowledge about databases like PUBMED, ARGUS and ARIS-G.

Collect the information about new indications, dosage form, route of administration, strength of the new products or existing products.

Experience in preparation and proofreading of FDA special 510k for class II, III products.

Good sound knowledge about regulations of medical devices for 510k, PMA, MDD (Medical Device Directive), IDE.

Knowledge about FDA regulations and guidelines for GCP’s, GLP’s, GMP’s, EPA.

Knowledge about International regulations of marketed and approved regulatory products.

Independently handled complete case processing review, events coding, collect and analyze the information about marketed and development stage products of Bio- Pharmaceutical companies including Medicinal product information, Clinical trial data, Drug delivery technology.

Knowledge about international guideline, regulations, ICH guidelines, Annual reports, Adverse event reporting, Events coding and Narrative writing.

Knowledge of NDA, INDA, USFDA, FDA 21 CFR.

Capacity to handle multiple projects.

Expertise in Narrative writing.

Through knowledge about Microsoft Excel, Microsoft Word.

Good team coordinator, quick learner, and self-encouraged nature.

Education:

MS in Information Studies – Trine University, Fort Wayne, IN, USA; Jan2016-May2017.

MS in Pharmacology- JNTU, Hyderabad, INDIA.

Bachelor’s in pharmacy-JNTU, Hyderabad, INDIA.

Work Experience:

Regulatory Affairs Associate Sep2017-Apr2018

ZimmerBiomet, Warsaw, USA

Review US regulatory data anddocumentation according to international standards.

Supported development of regulatory submission for implantable medicaldevices.

Summarize / document finding.

Evaluating events/incidences and reporting on them to regulatory authorities as required.

Prepared Technical files documentation.

Review the FDA regulatory submissionprocess.

Preparation and proofreads of FDAspecial 510k for class II, III products.

Post-market surveillance periodicupdates.

Review product changes and Impact on regulatory status of the products.

Review labelling, package inserts and surgical techniques for compliance with USand internationalregulations.

Druf Safety Specialist, May2011-Dec2015

Pfizer, Hydrabad,

Quality submissions as per FDA guidelines.

Prepare and review submissions of FDA, NDA applications of marketed and clinical trials based drugs and medical devices.

Collect and Analyzed clinical trials data and updates.

Completed data entry from source documents including a medical writing, complete the custodial review, detailing the adverse events, selection and coding of event terms, concomitant medications and medical history against the source documents updates in ARGUS data and validation.

Reviewed source documents such as Medical device reports, physician office records and hospital records and lab details for the cases received from legal offices/and theiragents.

Evaluated consistency, completeness, accuracy of safety database, tracking database and source document entryforms.

Safety narrative writing for all reports that meet potential expedited reporting requirements like 15NDA, CIOMS, PSURS with relevant CIOMS forms is forwarded electronically to regulatoryauthorities.

AEM form completion from the source documents, including the patient details, suspectdrug information, ADR’S, diagnosis and relateddetails.

Ensured and maintain consistency in the evaluation and assessement of adverse event reports.

Selection and coding of event terms using MedDRA browser and WHO drugdictionary.

Safety narrative writing of Non interventional study reports, marketing programs, legal documents which includes claim letters, summons and complaints, plaintiff’s fact sheet and medicalrecords.

Hands on experience in framing narratives in consistency with source documents and according to the templates assigned.

Generate queries and discuss with team members and send queries to the client and sort out the problems.

Responsible for submission of ADE reports.

Responsible for assessment of causality and reportability of an SAE report.

Therapeutic areas of work included pain and inflammation, cardiovascular, urology and sexual health, psychiatry and mental health system, neuroscience, social medicines, hormonal, pulmonary system, diabetes, infectious disease(s) and cancers (oncology)etc.

Assisted revised guidelines, SOP’s and instructions.

Possess knowledge in medical terminology, ICH-GCP guidelines, clinical research, FDA regulations (21CFR Part11), Pharmacovigilance (adverse eventreporting).

Well versed with applications like DIDE, Argus, GDMS, MedDRA and WHObrowsers.

Developed Standard Operation Procedures (SOPs).

Regulatory Affairs Associate 12/Jul/2010 to10/May/2011

CognizantTechnologySolutions, Hyderabad, INDIA

Tracked all the trial details from development stage to marketing which includes-preclinical, Phase I/II/III and IV of the existing productsand new products under development from sources like clinicaltrails.gov and regulatory bodies of thecountries.

Accumulated information pertaining to investigational and marketed drugs, biologics and medicaldevices.

To analyze the pipeline products by targeting particular therapeutic area using various available secondaryresources.

Captured data related to regulatory submissions like IND, NDA andPMA.

Competitors study in a territory for a particular indication according to companies’ product pipelines using various available secondaryresources.

Prepared reports from the gathered information with greataccuracy.

To collect and analyze the information of bio-pharmaceutical companies including product information, geography and market territory data,press release analysis and tracking, annual reports and SECfilings.

Processed quality assurance of the generatedreports. Handled regulatory queries fromclients.

Help in the approval process of post marketing products of NDA and ANDA.

Projects:

Review and proofread 510(k) notifications.

NDA and ANDA submissions.

IND submission.

USFDA submission.

Events coding.

MedDRA and WHO.

Medicinal products coding.

Labelling of products.

Narrative writing.

Quality analysis of medical records, Summons and Complaints, PFS’s.

Pharmaceutical Drug Manufacturing in India (Aurobindo Pharma).

Computer skills: MS office, Word, Excel, Power point

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