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.