Job Summary

The Process Specialist-CDM/PV role involves managing and optimizing processes within Pharma Research & Development. The candidate will contribute to enhancing safety operations and pharmacovigilance case processing. With a hybrid work model and rotational shifts the role demands adaptability and technical expertise. The position does not require travel

Responsibilities

• Oversee the management and optimization of processes within Pharma Research & Development to ensure efficiency and compliance.

• Provide support in pharmacovigilance case processing ensuring accurate and timely documentation of safety data.

• Collaborate with cross-functional teams to enhance safety operations and improve overall process effectiveness.

• Analyze data and generate reports to support decision-making and strategic planning in pharmacovigilance activities.

• Implement best practices and innovative solutions to streamline processes and improve productivity.

• Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations.

• Facilitate communication and coordination between different departments to achieve seamless workflow and process integration.

• Monitor and evaluate process performance identifying areas for improvement and implementing corrective actions.

• Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution.

• Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations.

• Utilize technical skills to troubleshoot and resolve process-related issues minimizing disruptions and ensuring smooth operations.

• Contribute to the continuous improvement of processes by providing insights and recommendations based on data analysis.

• Engage in rotational shifts to provide consistent support and coverage across different time zones.

Qualifications

• Possess a strong background in Pharma Research & Development with experience in pharmacovigilance case processing.

• Demonstrate proficiency in safety operations and regulatory compliance within the pharmaceutical industry.

• Exhibit excellent analytical skills and the ability to interpret complex data sets for informed decision-making.

• Show adaptability to work in a hybrid model and manage rotational shifts effectively.

• Have a keen eye for detail and a commitment to maintaining high standards of quality and accuracy.

• Display effective communication skills to collaborate with cross-functional teams and stakeholders.

• Be proactive in identifying process improvements and implementing innovative solutions.

• Hold a relevant degree in pharmaceutical sciences or a related field.

• Have a minimum of 2 years and a maximum of 4 years of experience in the pharmaceutical industry.

• Experience in PV Case Processing and Safety Ops is considered a valuable asset.

• Demonstrate the ability to work independently and as part of a team to achieve organizational goals.

• Show commitment to continuous learning and professional development in pharmacovigilance and safety operations.

• Be familiar with industry-standard software and tools used in pharmacovigilance and process management.