Pharmacovigilance -

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1. System and process development:

- Developing and reviewing Standard Operating Procedures (SOPs)

- Designing and maintaining quality management systems (QMS)

- Implementing and optimizing global pharmacovigilance systems

 

2. Regulatory and compliance support:

- Providing expert guidance on regulations (e.g., FDA, EMA, ICH)

- Preparing and submitting aggregate safety reports, like Periodic

  Safety Update Reports (PSURs)

- Developing and maintaining Risk Management Plans (RMPs)

- Conducting audits to ensure compliance

 

3. Safety data management:

- Managing safety databases, including set-up, validation, and migration

- Processing and reporting Individual Case Safety Reports (ICSRs)

- Performing medical reviews of adverse events

 

4. Clinical trial support:

- Developing site-specific safety management plans

- Providing training to investigators and monitors

- Performing data reconciliation between safety and clinical trial

  databases

 

5. Risk management and signal detection:

- Conducting literature reviews for potential safety signals

- Supporting safety committees for risk-benefit assessments and signal management

 

6. Document management:

- Maintaining Company Core Datasheets (CCDS)

- Reviewing and overseeing safety and efficacy documents