Drug Safety Associate I / Drug Safety Associate II
Drug Safety Associate I / Drug Safety Associate II
Posted on :
31-05-2025
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1 Vacancy
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Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
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
- Experience with computer applications
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
Required Experience:
IC
Employment Type
Full Time
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