Drug Safety Associate Resume Samples

Description :

1. Enter preliminary and follow-up information from source documents into the global adverse event database ArisG.
2. Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into adverse event database, review of entered cases for quality.
3. Participates in the triage process for incoming documents to ensure timely and effective medical and scientific evaluation of adverse event information.
4. Prepare medical narratives and assign MedDRA terms to adverse events while maintaining consistency with the ArisG database.
5. Submissions of CIOMS/MedWatch forms and serious cases to regulatory authorities including the FDA and EU.
6. Assisting with preparation and review of regulatory reports. Request follow-up information from consumers, and health care professionals.
7. Maintain knowledge and understanding of SOPs and current FDA regulations.

Experience

7-10 Years

Level

Management

Education

MBA

Description :

1. Maintain a log of source documents and other communications. Case intake, duplicate check, and registration using the ARISg safety database.
2. Performed data entry, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case.
3. Assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines.
4. Received and documented incoming telephone calls, faxes or emails from investigative sites or other sources.
5. Suspect company drugs and WHO drug dictionaries to code historical, concomitant and treatment medications.
6. Identified potential product complaints to forward and perform all appropriate coding and write case narratives for adverse events.
7. Attended project team meetings and provided feedback to the operations manager on any challenges/issues or successes.

Experience

5-7 Years

Level

Executive

Education

Business Administration

Description :

1. Generated queries using ARGUS interface for clarification, resolving and forwarding to the next workflow and communicated to outside sources.
2. Consistently used ARGUS features such as action items, contact log and work list for communication and for the follow-up requests.
3. Verification of accuracy and consistency Identify and select routine cases for processing, determining appropriate prioritization.
4. Assessed cases to distinguish those with particular complexities and/or specific issues, and escalated to the respective team or an individual.
5. Generate reports, ensuring adherence to regulatory compliance timelines.
6. Determine and perform appropriate case follow-up, generating and requesting follow-up letters.
7. Developed and expertise on a portfolio of company products within a therapeutic area with respect to the data entry conventions.

Experience

2-5 Years

Level

Junior

Education

MBA

Description :

1. Handled Literature search for adverse events and assessing for valid cases as per client requirements.
2. Reviewing of spontaneously reported adverse reactions, literature adverse events, follow-up information and/or other medically related information.
3. Processing of literature, spontaneous, clinical trial, authority and observational study cases in ARGUS safety database.
4. Generation of line listings from the Empirica trace (Clin trace) database and submission to the regulatory reporting team.
5. Generation and submission of CIOMS and XML to the regulatory team.
6. Coding of company and non-company suspect drugs as per the requirement of the client.
7. Processing of case inactivation requests from other DSAs and communication to a client for inactivation of cases.

Experience

10+ Years

Level

Senior

Education

Diploma

Description :

1. Identify and select the cases from a workflow, determining appropriate prioritization criteria and submission dates.
2. Compliance with process requirements Reviews the coding of suspect drugs using the Company Drug Dictionary and WHO Drug Dictionary.
3. Review the coding of Concomitant Drugs, Treatment Drugs and Past Drugs using the WHO Drug Dictionary.
4. Review the seriousness criteria of all the events and upgrade the events listed in "Always Serious List", following the established procedure.
5. Adverse Events, Indications of Suspect and Concomitant medications, Medical History and Laboratory investigations as per coding conventions.
6. Write the narrative in a chronological format and do the quality check of the cases processed before reporting to the regulatory.
7. Labeling the events according to the Company Core Data Sheet.

Experience

2-5 Years

Level

Junior

Education

Diploma

Description :

1. Maintain a strong understanding of Covance's Argus database conventions or client-specific database conventions, as appropriate.
2. Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports.
3. Work with Data Management or client on reconciliation of safety databases.
4. Participated in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
5. Support/train less experienced scientists in all aspects of case-handling, adverse event reporting.
6. Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs, and safety processing guidelines.
7. Build and maintain good drug safety relationships across functional units. Demonstrate role-specific Competencies on a consistent basis.

Experience

5-7 Years

Level

Executive

Education

Integrated Studies

Description :

1. Receipt and confirmation of receipt of information regarding serious and non-serious adverse events from multiple sources.
2. Duplicate check in the database and Triaging of cases. Assessment of seriousness and labeling of the events.
3. Data entry of adverse events, medical history, concomitant medications into the ArisG database, MedDRA.
4. Review of source documents such as physician's records and lab details for the case review.
5. Following up with the investigator and other ICSR sources for further event-related information.
6. Performing QC of all the entered data before forwarding the case to the next workflow.
7. Liaise with the Medical reviewing team for any coding relevant queries.

Experience

2-5 Years

Level

Junior

Education

Master Of Science

Description :

1. Processed and conducted quality assurance of Clinical Trial and Postmarketing Adverse Event reports.
2. Triaged and registered incoming Adverse Event Reports to determine seriousness for prioritization of daily workflow.
3. Performed duplicate and database searches as necessary.
4. Worked on literature cases, solicited cases, individual patient use cases, spontaneous cases, pregnancy cases, literature cases.
5. Identified and worked on potential signal detection cases.
6. Performed comprehensive narrative writing and case data entry according to standard operating procedures.
7. Performed Medical coding using MedDRA and WhoDD in accordance with ICH GCP guidelines Performed labeling, listing.

Experience

10+ Years

Level

Senior

Education

Clinical Research

Description :

1. Preparation of case narratives in ARGUS, always following the ICH and FDA guidelines in the process and medical writing.
2. Collection of information pertaining to the safety and efficacy of marketed products.
3. Labeling edit checks by reviewing event labeling from the processed cases against SmPC (SPC), USPI and CCSI.
4. Presenting proposed labeling revisions to the labeling committees for review.
5. To identify clinically relevant information missing from the case reports and facilitate its collection by preparing follow-up requests/letters.
6. Compilation and preparation of PSURs, DSUR safety reports, NDA/IND annual reports, as well as ad-hoc reports.
7. Conducted periodic reconciliation of Serious Adverse Events between clinical trial and safety databases.

Experience

2-5 Years

Level

Junior

Education

Pharmacology

Description :

1. Calling patients, making notes, writing AE documentation and reports - drug safety project.
2. Worked with Clinical Research Documents, calling doctor's offices.
3. Provide high -level quality in electronic and paper-based data management of clinical data Ensured establishment, retention.
4. Prepared clinical records for new patients upon receipt of referral.
5. Maintained a control procedure for active patient files.
6. Maintain a tracking system to ensure clinical records are current according to company policy and regulatory requirements.
7. Partner with clinical resources to oversee patient intake and inquiries and assess patient needs.

Experience

2-5 Years

Level

Junior

Education

Data Management

Description :

1. Medical and drug terminology In-depth knowledge in coding using MedDRA and WHO-DD.
2. Experience in creating safety reports for medical devices Effectively done literature surveillance and the creation of safety reports.
3. Worldwide regulatory requirements and reporting of adverse events for marketed products.
4. In-depth knowledge of ICH safety reporting regulations, GCP and other guidelines.
5. Attained knowledge in PSUR clean-up and related activities. Excellent written and verbal communication skills.
6. Interaction on a regular basis with affiliates and other stakeholders to resolve safety-related issues.
7. Completed protocol request forms as necessary.

Experience

5-7 Years

Level

Executive

Education

Diploma