SPE-Pharmacovigilance

Job Summary

We are seeking a skilled data Pharmacovigilance Specialist with 3 to 5 years of experience in Pharma Research and Development. The ideal candidate will contribute to ensuring the safety and efficacy of pharmaceutical products. This hybrid role requires a proactive approach to case processing and research with a focus on improving patient outcomes and supporting the companys mission to enhance public health.

Responsibilities

• Monitor and evaluate adverse event reports to ensure compliance with regulatory requirements and company standards.
• Collaborate with cross-functional teams to analyze safety data and identify potential risks associated with pharmaceutical products.
• Develop and implement risk management strategies to mitigate identified safety concerns and enhance product safety profiles.
• Prepare and review safety reports and documentation for submission to regulatory authorities.
• Conduct thorough literature reviews to stay updated on the latest developments in pharmacovigilance and drug safety.
• Provide expert guidance on safety-related issues to internal stakeholders and contribute to decision-making processes.
• Participate in the development and maintenance of pharmacovigilance systems and databases to ensure accurate and efficient data management.
• Support the training and mentoring of junior staff members in pharmacovigilance practices and procedures.
• Engage in continuous improvement initiatives to enhance the efficiency and effectiveness of pharmacovigilance activities.
• Ensure timely and accurate case processing adhering to established timelines and quality standards.
• Collaborate with research and development teams to integrate safety considerations into product development processes.
• Contribute to the development of safety-related policies and procedures to ensure compliance with industry best practices.
• Communicate effectively with external partners and regulatory agencies to address safety-related inquiries and issues.
  
  

• Possess a strong background in Pharma Research and Development with a focus on pharmacovigilance.
• Demonstrate expertise in PV Case Processing and familiarity with relevant regulatory guidelines.
• Exhibit excellent analytical and problem-solving skills to identify and address safety concerns.
• Show proficiency in using pharmacovigilance databases and software for data management.
• Have strong communication skills to effectively collaborate with cross-functional teams and external stakeholders.
• Display a commitment to continuous learning and staying updated on industry trends and advancements.