Freshers Drug Safety Associate at Parexel – Life Sciences Apply
Freshers Drug Safety Associate at Parexel – Life Sciences Apply. Drug Safety Associate. Parexel Drug Safety Associate careers. Parexel has job openings for life sciences candidates. Check out all of the details on the same below:
Parexel Vacancy Details
Designation: Drug Safety Associate I
Requisition ID: 60808BR
Location: Chandigarh, Chandigarh, India
Accountability Supporting Activities:
- Maintaining a great working knowledge of the adverse event safety profile of the assigned drugs, labelling documents, client’s guidelines, and also SOPs, and also Global drug safety regulations
- Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and also regulatory timelines for the adverse event reporting
- Help in the development of project-specific safety procedures, workflows and also templates
- Attend internal, drug safety and project-specific training sessions
- Finishes training assigned on internal and also client Learning Management System (LMS) as applicable
- Prep work for, participation in, and follow up on audits as well as inspections
- Maintaining an awareness of the performance matrices measured by the client and striving to remain within established limits
- Delegate work as appropriate to Drug Safety Assistants
- Liaising as well as collaborating with the relevant function at the client’s end to help with the delivery of high-quality work
- Determines areas of concern and also raising the issues with the manager
- Archiving the source documents as well as relevant e-mails as required
- Responds to clients/customers in a timely manner
- Monitoring of incoming reports from various sources viz mailboxes, EudraVigilance, literature searches etc.
- Perform literature searches according to search strategy, performs data entry of valid cases right into the safety database
- Triage of incoming reports for completeness, legibility and also validity, consisting of literature abstracts/articles/citations
- Responsible for sending translation requests, if any
- Compares and analyses data provided by the affiliate with the data available on the client application
- Prepares ADR form/cover sheet as required
- Addition of brand-new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool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 as well as seriousness criteria are accurate for the events.
- Guarantees MedDRA coding based on “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 top quality checks/validation checks.
Keep in mind: The above statements describe the general nature as well as the level of the work being performed and also are not an exhaustive list of all responsibilities required for the position.
- Analytical and also analytical skills.
- Outstanding interpersonal skills.
- Excellent verbal/ written communication skills.
- Excellent organizational and prioritization skills.
- Capability to work collaboratively as well as efficiently in a team environment.
- Client focused approach to work.
- Capability to evaluate data and also draw conclusions independently.
- Computer proficiency, IT skills, the expertise and also an ability to deal with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/PowerPoint).
Knowledge and also Experience:
- 0-2 years of experience.
- Good knowledge of medical terminology.
- Related experience gained in a health care environment is an advantage.
- Degree in Life Sciences (Microbiology, Biochemistry, Biotechnology, Biophysics etc.).
- A degree in Medicine/Dentistry/physiotherapy/ Experimental Medicine/Nursing, which entails patient exposure in a hospital-based environment, would be an advantage.
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