Job Description

Job SummaryWe are seeking a dedicated Senior Process Executive for CDM/PV with 2 to 4 years of experience. The ideal candidate will have strong technical skills in MS Excel and a background in PV Case Processing Pharmacovigilance and Safety Ops or Research and Development. This role involves ensuring data accuracy compliance and contributing to the overall safety and efficacy of pharmaceutical products.Responsibilities * Ensure accurate data entry and management using MS Excel to maintain high-quality records.

• Oversee the processing of pharmacovigilance cases to ensure compliance with regulatory requirements.
• Provide support in the preparation and submission of safety reports to regulatory authorities.
• Collaborate with cross-functional teams to ensure timely and accurate case processing.
• Monitor and evaluate data to identify trends and potential safety issues.
• Assist in the development and implementation of standard operating procedures for case processing.
• Conduct regular quality checks to ensure data integrity and accuracy.
• Support the development of training materials and provide training to junior staff.
• Participate in audits and inspections to ensure compliance with regulatory standards.
• Contribute to the continuous improvement of pharmacovigilance processes and systems.
• Maintain up-to-date knowledge of regulatory requirements and industry best practices.
• Provide timely and accurate responses to queries from internal and external stakeholders.
• Ensure all activities are conducted in accordance with company policies and procedures.

Qualifications * Possess strong technical skills in MS Excel for data management and analysis.

• Have experience in PV Case Processing Pharmacovigilance and Safety Ops or Research and Development.
• Demonstrate excellent attention to detail and accuracy in data entry and management.
• Exhibit strong organizational and time management skills.
• Show ability to work collaboratively in a team environment.
• Display excellent communication skills both written and verbal.
• Have a proactive approach to problem-solving and continuous improvement.
• Be familiar with regulatory requirements and industry best practices in pharmacovigilance.
• Show ability to handle multiple tasks and prioritize effectively.
• Demonstrate experience in developing and implementing standard operating procedures.

Certifications RequiredCertified Pharmacovigilance Professional (CPP) or equivalent certification in pharmacovigilance.

Cognizant