Pharmacovigilance Specialist

Job Overview:

The Pharmacovigilance Specialist will be responsible for monitoring, evaluating, and reporting on the safety of pharmaceutical products. This role is crucial for ensuring compliance with regulatory requirements and for maintaining the safety and efficacy of products throughout their lifecycle.

Key Responsibilities:

• Adverse Event Monitoring:
  • Collect, evaluate, and analyze adverse event reports from various sources (clinical trials, post-marketing surveillance, etc.).
  • Conduct thorough investigations of reported adverse events to determine causality and severity.
• Regulatory Compliance:
  • Prepare and submit safety reports and documentation to regulatory authorities in accordance with local and international guidelines.
  • Ensure adherence to Good Pharmacovigilance Practices (GVP) and company policies.
• Data Analysis:
  • Utilize statistical methods and tools to assess safety data and identify trends or signals related to product safety.
  • Maintain and update safety databases and ensure data integrity.
• Collaboration:
  • Work closely with cross-functional teams including Clinical Research, Regulatory Affairs, and Quality Assurance to support product safety initiatives.
  • Liaise with external partners, healthcare professionals, and regulatory agencies as needed.
• Documentation and Reporting:
  • Prepare and maintain comprehensive documentation of safety data, assessments, and regulatory submissions.
  • Contribute to Risk Management Plans (RMPs) and other safety-related documents.
• Training and Education:
  • Provide training and support to staff on pharmacovigilance processes and regulatory requirements.
  • Stay updated on industry trends and changes in regulations affecting pharmacovigilance.

Qualifications:

• Education:
  • Bachelor’s degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred.
• Experience:
  • 8 + years of experience in pharmacovigilance, drug safety, or related areas within the pharmaceutical industry.
  • Familiarity with global regulatory requirements and guidelines (e.g., FDA, EMA).
• Skills:
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Proficiency in pharmacovigilance databases and software.
• Certifications:
  • Certification in pharmacovigilance or drug safety (e.g., from a recognized professional body) is a plus.

Working Conditions:

• Office-based position with potential for remote work flexibility.
• May require occasional travel for training or meetings.