Drug Safety Associate I

6 days ago

Mohali Punjab, India Parexel Full time

The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

**Key Accountabilities**:
**Drug Safety Support**:

- Assist in development of project specific safety procedures, workflows and template
- Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing
- Triage incoming reports for completeness, legibility, and validity
- Electronic documentation and quality control of drug safety information
- Data entry of case reports into safety database / tracking system
- Request follow-up and perform query management
- Coding of data in the safety database
- Writing case narratives
- Create and maintain project specific working files, case report files and project central files
- Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required
- Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects
- Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities
- Participate in client and investigator meetings as required
- Attend internal, drug safety and project specific training sessions
- Perform literature searches
- Preparation for, participation in, and follow up on audits and inspections
- Delegate work as appropriate to Drug Safety Assistants
- Assistance in development of Expedited Reporting Procedures
- Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor
- Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
- Submission of safety reports to investigators via ISIS (International Safety Information System)
- Assist with measuring investigative site performance in conducting required tasks in ISIS
- Tracking and filing of submission cases as required
- Assist with unblinding of SUSARs, as required
- Support collection and review of metrics for measuring reporting compliance

**Skills**:

- Analytical and problem-solving skills
- Able to perform database/literature searches
- 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

**Knowledge and Experience**:

- Related experience gained in a healthcare environment is an advantage
- minimum 1+ years of relevant experience in PV. Experience in PV database like LSMV (LifeSphere Multivigilance) is preferred.**Education**:

- Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience
- Associates degree in any of the above with appropriate work experience

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