ProductLife Group is a globally renowned service provider specializing in regulatory compliance and lifecycle management in the healthcare sector. With an impressive track record, the company focuses on delivering innovative solutions, particularly in pharmacovigilance, medical device compliance, and regulatory services. Currently, ProductLife Group is seeking a Data Officer to support their pharmacovigilance activities. This role offers a chance to contribute to ensuring drug safety and regulatory compliance.
Responsibilities in the Job
As a Data Officer (Pharmacovigilance), your core responsibilities will include:
- Data entry of vigilance cases in relevant databases.
- Preparing initial emails for follow-up requests or clarification.
- Submitting cases to competent authorities.
- Running specific database queries to draft reports.
- Monitoring and downloading ICSRs (Individual Case Safety Reports) via Eudravigilance and MHRA portals.
- Managing a generic mailbox and supporting registration, initial triage, and data updates.
- Performing quality control checks on vigilance cases.
- Recording and updating information on XEVMPD.
- Drafting and updating technical agreements, safety management plans, and client templates.
- Assisting with the preparation of SOPs (Standard Operating Procedures), WPDs (Work Process Documents), and training materials related to your activities.
- Participating in the continuous improvement of processes within the department.
Qualifications
To be eligible for this role, you should meet the following qualifications:
- A Bachelor’s degree in a science-related field.
- Freshers or candidates with up to one year of experience in pharmacovigilance are welcome to apply.
- Familiarity with Outlook and Microsoft Office.
Skills
Successful candidates should demonstrate:
- Experience with databases is preferred.
- Strong organizational and process-oriented mindset.
- Comfort working with documentation and reports.
- Good computer skills and proficiency in English, with French being an added advantage.
- The ability to work well within a team.
- Knowledge of medical terminology is essential.
- Flexibility and adaptability in handling various tasks.
