SME-Pharmacovigilance

Job Summary

We are seeking a Subject Matter Expert in Pharmacovigilance with 2 to 4 years of experience to join our team. The ideal candidate will have a strong background in Pharma Research & Development and a keen interest in PV data management and case processing. This hybrid role offers the opportunity to work in a dynamic environment contributing to the safety and efficacy of pharmaceutical products.

Responsibilities

• Conduct thorough analysis of pharmacovigilance data to ensure compliance with regulatory standards and enhance drug safety.
• Collaborate with cross-functional teams to support the development and implementation of pharmacovigilance strategies.
• Provide expert guidance on PV case processing to ensure accurate and timely reporting of adverse events.
• Utilize technical skills in Pharma Research & Development to drive innovation and improve pharmacovigilance processes.
• Monitor and evaluate the effectiveness of pharmacovigilance systems and recommend improvements.
• Develop and maintain comprehensive documentation of pharmacovigilance activities and findings.
• Assist in the preparation of regulatory submissions and safety reports to ensure compliance with global standards.
• Engage in continuous learning to stay updated on the latest trends and advancements in pharmacovigilance.
• Support the training and development of team members to enhance overall team performance.
• Ensure data integrity and accuracy in all pharmacovigilance activities to maintain high-quality standards.
• Participate in audits and inspections to demonstrate compliance with regulatory requirements.
• Foster a culture of safety and vigilance within the organization to protect public health.
• Contribute to the companys mission by ensuring the safe and effective use of pharmaceutical products.

Qualifications

• Possess a strong foundation in Pharma Research & Development essential for driving pharmacovigilance initiatives.
• Demonstrate expertise in PV data management and case processing enhancing the quality of safety assessments.
• Exhibit excellent analytical skills to interpret complex pharmacovigilance data and derive actionable insights.
• Show proficiency in regulatory compliance ensuring adherence to global pharmacovigilance standards.
• Display effective communication skills to collaborate with cross-functional teams and stakeholders.
• Maintain a proactive approach to problem-solving ensuring timely resolution of pharmacovigilance issues.

Certifications Required

Certified Pharmacovigilance Professional (CPP) or equivalent certification preferred.