Drug Safety Associate

hace 2 días

Madrid, España Parexel A tiempo completo

**Job Purpose**:
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 templates
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

**Qualifications**:**
Knowledge and Experience**:

- Related experience gained in a healthcare environment is an advantage
**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

**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

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