PE-Pharmacovigilance

Job Summary

Join our dynamic team as a Pharmacovigilance Specialist where you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products. With a focus on data analysis and case processing you will contribute to our mission of improving patient safety. This hybrid role offers a unique opportunity to work in a rotational shift environment providing flexibility and exposure to diverse projects.

Responsibilities

• Monitor and evaluate adverse event reports to ensure compliance with regulatory requirements and company standards.
• Utilize MS Excel to analyze and interpret pharmacovigilance data identifying trends and potential safety signals.
• Collaborate with cross-functional teams to ensure accurate and timely case processing and reporting.
• Assist in the preparation of safety reports and regulatory submissions contributing to the overall safety strategy.
• Support the development and maintenance of pharmacovigilance databases and systems.
• Participate in the review and assessment of safety data providing insights and recommendations for risk management.
• Conduct quality checks on case processing activities to ensure data accuracy and completeness.
• Engage in continuous learning and development to stay updated with industry best practices and regulatory changes.
• Contribute to the development and implementation of pharmacovigilance processes and procedures.
• Provide support in the training and mentoring of junior team members fostering a collaborative work environment.
• Ensure effective communication with internal and external stakeholders to facilitate the exchange of safety information.
• Participate in audits and inspections ensuring readiness and compliance with regulatory standards.
• Drive initiatives to improve pharmacovigilance processes enhancing efficiency and effectiveness.
  
  

Qualifications

• Demonstrate proficiency in MS Excel with the ability to analyze and interpret complex data sets.
• Possess a foundational understanding of pharmacovigilance principles and practices.
• Exhibit strong attention to detail and analytical skills ensuring accuracy in case processing.
• Show willingness to work in a rotational shift environment adapting to changing schedules.
• Display excellent communication and teamwork skills contributing to a collaborative work culture.
• Have a basic knowledge of PV Case Processing which is considered an advantage.