Experience Summary

*.* years’ experience as Drug Safety Associate.

3.5 years’ experience of proficiency in MS Word, MS Excel, MS power point.

1.5 years’ experience for date entry in Arisg software and handling of Clinical trials cases, performing CT reconciliations and had a strong hold on Adhoc activities. Having thorough knowledge of all CT SOPs along with their reporting plans.

2 years’ experience as Associate Dentist.

2 years’ experience as Admin executive.

Technical Skills

FDA Drug Safety Guidelines

ARISG Software

I-medidata software

Micromedex

Drug Safety

MS Office

Flexible and Adaptable

Data Entry

Decision-Making

Self-Motivated

Proficiency

Teamwork and Collaboration

Education

BDS (Bachelors of dental surgery), RBDCH, Mohali 2013 – 2018

10+2 (Senior Secondary), Sacred Heart Convent School, Khanna 2010

10th (Secondary), Sacred Heart Convent School, Khanna 2008

Work Experience

U-HAUL, BRAMPTON Nov-2022

Customer Service Representative

Assist customers inside and outside U-Haul Center with U-Haul products & services

Use smartphone-based U-Scan technology to manage rentals and inventory

Move and hook up U-Haul trucks and trailers

Clean and inspect equipment on the lot including checking fluid levels

Answer questions and educate customers regarding products and services

Prepare rental invoices and accept equipment returned from rental

PAREXEL INTERNATIONAL, MOHALI Jun 2021- Sep 2022

Drug Safety Associate I

• Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling doc and SOPs, and Global drug safety regulations.

Assist in development of project specific safety procedures, workflows and templates.

• Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting.

• Attend internal, drug safety and project specific training sessions.

• Preparation for, participation in, and follow up on audits and inspections.

• Delegate work as appropriate to Drug Safety Assistants.

• Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work.

• Responds to clients/customers in a timely manner.

• Acting as a Subject Matter Expert for clinical team

Case Processing

• Monitoring of incoming reports from various sources viz mailboxes, EudraVigilance, literature searches etc.

• Perform literature searches as per search strategy, performs data entry of valid cases into the safety database.

• Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations.

• Perform a check on overall medical cohesiveness and consistency of the document.

• Compares and analyses data provided by the affiliate with the data available on client application.

• Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool.

• Creates the case on the safety database.

• Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs).

• Review ancillary documentation accompanying ICSRs and identifying the relevant information for processing and capture on the client safety database.

• Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events.

• Ensures MedDRA coding in accordance with “MedDRA Term selection: Points to Consider”.

• Ensure that the reports are scheduled for submissions, as required.

• Performs quality checks/validation checks to ensure accuracy of information captured, and that expectedness, causality and seriousness are correctly assessed.

• Supports compliance activities including late case investigation of ICSRs to various Health Authorities and business Partners to determine the assignable cause for lateness, collection of lateness documentation including corrective actions, where applicable.

• Responsible for mentoring of drug safety associate-I to ensure confident coding of ICSRs.

• Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable.

Drug Safety Reporting

• Quality control of case reports, line listings, and tabulations.

• Performing submissions of cases and aggregate reports within stipulated timelines through client safety database,

Eudravigilance, Common European Submission Portal (CESP) and other modes of submissions (e.g. courier, email, etc.), as applicable and to provide submissions ready documents to Named Contract Person (NCP) in a timely manner.

• Maintain local drug safety reporting requirements.

• Perform registration with relevant authorities for electronic reporting on behalf of sponsor.

• Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy).

• Unblinding of SUSARs, as required

• Collect and review metrics for measuring reporting compliance

AKALCHET DENTAL CLINIC, CHANDIGARH Jan 2019 – Jun 2021

Associate Dentist

Amalgam, composite and GIC restorations.

Root canal treatment.

Complete dentures and removable partial dentures.

Administration of local anaesthesia and painless deciduous and permanent tooth extractions.

Alveoloplasty.

Hand and ultrasonic scaling.

Radiological interpretations.

Good knowledge of handling dental equipment and patients.

Good idea about oral and dental diseases and their treatment.

SAINI STEELS, MANDI GOBINDGARH JUN 2011– Sep 2013

Admin Executive

Customer relationship management, administration paperwork, appointment coordination and record keeping for reference.

Increase customer service success rates by quickly resolving issues.

Effective communication and interpersonal skills developed by answering direct telephonic customer service calls and provided customized solutions to meet their individual needs.

Advanced Microsoft office skills: Excel, power point and word.

Multi-tasking and organizing skills developed by working on various assignments simultaneously and managing scheduled workload by effectively prioritizing tasks.

Manage office operations and scheduling customer appointments.

Preparing and editing letters and other documents.

Greet visitors and direct them to employer or appropriate person.

Ordering and maintain minimum inventory level of office supply.

Printing and photocopying of relevant documents as per requirements.

Organizing travel plans and making booking and other arrangements for staff members.

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