Namrata Sharma

Westborough, MA, *****

ac4lu5@r.postjobfree.com 215-***-****)

Summary

Highly motivated and efficient individual with 3+ years of experience in the field of medical device in a sensitive corporate environment. Committed to the field of research and development with the aim of improving standards of medicine with the use of technological advances.

Skills

• Experienced in documenting and assisting clinical trial research.

• Clear, concise and effective written and verbal communication skills.

• Strong organizational, computer and problem-solving skills.

• Through knowledge of FDA and GCP principles and regulations.

• Detail-oriented, fast learner, good listener and a team player. Professional experience

PMV/Complaint Analyst

Fresenius Medical Care, Waltham, MA (01/18 - Till date)

• Initiates and manages the complaint file, maintains accurate entry of complaints.

• Communicates to international offices, physicians, hospitals personnel, Sales representatives.

• Independently asses the complaints to determine if a medical device report needs to file with various global regulatory agencies (FDA, ECA).

• Submits reports within the required timeframe.

• Diligent of any unusual trends in product complaints and communicates them with management.

• Complies with US FDA regulations, other regulatory requirements, company policies, operating procedure, processes and task assignments.

• Maintains positive and cooperative communications and collaborations with all levels of employees, customers.

• Ensures appropriate governance of the complaint coding. QA/ RA (Consumer Affair Specialist)

Medtronic, Mansfield, MA (07/17 -12/17)

• Evaluates incoming complaint information and maintains it in the electronic database.

• Determines report-ability (MDR/AE) of complaints to FDA and other international regulatory agencies.

• Works closely with customers and sales representatives to respond to complaint reports.

• Closely monitors quality, completeness and timeliness of complaint investigations and files.

• Reviews, analyzes on complaint data and escalate issue and trends to Management and other departments as needed.

• Works with cross functional teams to ensure proper communication product analysis and evaluation/investigation of customer issues.

• Participates in team decision making and displays team problem solving/communication skills.

• Complies with all health, safety and environmental policies.

• Through knowledge of Med watch form FDA 3500A/MDR submission

• Efficient in Regulatory Decision trees(RD)/Regulatory Reporting (RR)/CRLs

• Good knowledge of Global complaint handling/SAP

• Works on SR/PE/Product Analysis/investigation/Reassessment

• Knowledge of literature Review

Clinical Research Associate (CRA)

Soller’s Institute/Q-tech Solutions (02/16 -06/17)

• Providing support to the project team and executing additional responsibilities.

• Performing documentation and monitoring of all clinical research trial data

• Updating knowledge of standard protocols for projects and resolving queries

• Ensuring the site is prepared as per standard protocols and current regulations

• Compiling and verifying completeness of all essential documents necessary to proceed with trials and maintaining highest level of confidentiality

• Filing, drafting, submitting, retrieving and reviewing case reports

• Attending training(s), meetings and teleconferencing as required

• Reviewing and correcting discrepancies in clinical research data

• Examining regulatory documents and monitoring reports

• Communicating and documenting every single step taken in the trial

• Establishing and maintaining Trial Master files in digital and physical formats

• Verifying reports are complaint with ICH guidelines, IRB /FDA requirements and Sops

• Reviewing Informed consent and making sure it is IRB approved and is of the latest version

QA/RA Specialist (Medical Devices)

Medical precision, War-minister, PA (01/15 -01/16)

• Conducting quality control according to the regulatory requirement

• Following company Sops and Protocols and GMP guidelines

• Attending routine weekly and other meetings and stay abreast of information

• Drafting meeting agenda and assisting in preparing meeting minutes

• Actively managing sample shipments

• Assisting in preparation of regulatory documents for Audits

• Ensuring proper and timely filing of all relevant study documents

• Performed detailed analysis of returned customer units and use findings to drive CAPA improvements

• Monitoring and reporting equipment calibrations

• Resolving queries and reporting discrepancies

• Handling of the inbound complaints regarding devices Worked closely with customers through CRLs/phone calls

Education

• Masters in Sociology

• Certified in Advanced Clinical Research

Affiliations

• Association of clinical research professionals

• The Society of Clinical Research Associate

Publications

• Translated a book -'We need to go to school' (The voices of Rugmark children.)

• Published a Dissertation on 'Status of Children' (A case study of rehabilitation center of Rugmark.)

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