Drug Safety Associate I

Accountability Supporting Activities

General • Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations

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

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

• Attend internal, drug safety and project specific training sessions

• Completes trainings assigned on internal and client Learning Management System (LMS) as applicable

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

• Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits

• 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

• Identifies areas of concern and raising the issues with the manager

• Archiving the source documents and relevant emails as required

• Responds to clients/customers in a timely manner

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

• Responsible for sending translation requests, if any

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

• Prepares ADR form/coversheet as required

• Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool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

• 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”

• Request follow-up and perform query management, as applicable

• Prepares medically cohesive case narratives based upon the reported information

• Routes the case to the next workflow state as applicable in the safety database

• Performs quality checks/validation checks

Note: The above statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities required for the position.

Skills:

• Analytical and problem-solving skills

• Excellent interpersonal skills

• Excellent verbal / written communication skills

• Excellent organizational and prioritization skills

• Ability to work collaboratively and effectively in a team environment

• Client focused approach to work

• Ability to evaluate data and draw conclusions independently

• Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)

Knowledge and Experience:

• 0-2 years of experience.

• Good knowledge of medical terminology.

• Related experience gained in a healthcare environment is an advantage.

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QualificationsEducation:

• Degree in life Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.).

• A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage