Adverse Event Reporting (AER):
- Collection and assessment of adverse drug reactions (ADRs) reported by healthcare providers, patients, or through clinical studies.
Signal Detection:
- Monitoring data from various sources (e.g., clinical trials, post-marketing reports) to identify patterns or "signals" of potential drug safety issues.
Risk Management Planning:
- Development of risk management plans (RMPs) to ensure that the benefits of a drug outweigh its risks throughout its lifecycle.
Case Processing:
- Evaluation and management of individual case safety reports (ICSRs), including data entry, assessment, and reporting to health authorities.
Regulatory Reporting:
- Submission of adverse event reports to regulatory agencies such as the FDA (US), EMA (Europe), and MHRA (UK), according to local laws and guidelines.
Literature Monitoring:
- Regular review of medical and scientific literature to identify new safety information related to drugs and report findings as per regulatory requirements.
Aggregate Reporting:
- Preparation and submission of periodic safety update reports (PSURs) or periodic benefit-risk evaluation reports (PBRERs), which summarize a drug's safety profile over time.
Clinical Trial Safety Monitoring:
- Ongoing monitoring of drug safety during clinical trials, including the identification and reporting of serious adverse events (SAEs).
Pharmacoepidemiology Studies:
- Studies designed to assess the long-term safety and effectiveness of drugs, often carried out as part of post-marketing surveillance.
Safety Data Exchange Agreements (SDEAs):
- Agreements between pharmaceutical companies to share safety data and ensure compliance with pharmacovigilance obligations.
Regulatory Compliance:
- Ensuring that all pharmacovigilance activities meet global regulatory standards and guidelines.
Patient Safety and Risk Minimization Activities:
- Implementing strategies like education campaigns, product labeling updates, or restricted access programs to minimize drug-related risks.
Audits and Inspections:
- Regular audits and inspections by regulatory bodies to ensure the effectiveness of a company’s pharmacovigilance system.