Job Summary:
The Pharmacovigilance Specialist monitors and evaluates the safety of pharmaceutical products, ensuring compliance with regulatory requirements. This role involves assessing adverse drug reactions (ADRs), managing safety data, and supporting risk management activities to enhance patient safety.
Key Responsibilities:
- Safety Monitoring:
- Collect, review, and analyze adverse drug reaction reports from various sources.
- Monitor and assess safety data to identify potential safety concerns and trends.
- Regulatory Compliance:
- Ensure compliance with local and international regulations related to drug safety.
- Prepare and submit regulatory reports, including Periodic Safety Update Reports (PSURs) and Risk Evaluation and Mitigation Strategies (REMS).
- Risk Management:
- Develop and implement risk management plans to mitigate safety risks.
- Conduct risk assessments and support the development of safety communication materials.
- Data Management:
- Maintain and manage safety databases, ensuring data accuracy and integrity.
- Collaborate with cross-functional teams to integrate safety data into product development and marketing strategies.
- Reporting and Documentation:
- Prepare detailed safety reports and documentation for internal and external stakeholders.
- Respond to safety-related inquiries and provide expert input on safety matters.
Qualifications:
- Education: Bachelor’s degree in Pharmacy, Life Sciences, or a related field (advanced degree preferred).
- Experience: [X] years of experience in pharmacovigilance or drug safety.
- Skills:
- Strong understanding of pharmacovigilance regulations and practices.
- Excellent analytical, communication, and organizational skills.
- Proficiency with safety databases and reporting tools.
Working Conditions:
- Hours: Full-time position, with standard office hours and potential for flexibility or remote work.
- Environment: Office or remote setting, with collaboration through digital communication tools.