Job Title: Senior Process Executive - CDM/PV
Location: [Location]
Job Summary:
We are seeking a dedicated Senior Process Executive with 2 to 3 years of experience in Clinical Data Management (CDM) and Pharmacovigilance (PV). The ideal candidate will have strong expertise in MS Excel and a solid background in PV case processing. This role involves managing and processing pharmacovigilance cases, ensuring compliance with regulatory requirements, and contributing to research and development initiatives.
Key Responsibilities:
- Case Management: Oversee the management and processing of pharmacovigilance cases to ensure compliance with regulatory standards.
- Data Entry: Ensure accurate and timely entry of data into the PV database.
- Reporting: Support the preparation of safety reports and regulatory submissions.
- Collaboration: Work closely with cross-functional teams to ensure the accuracy and completeness of case information.
- Data Analysis: Utilize MS Excel to analyze PV data and generate insightful reports.
- Quality Assurance: Conduct quality checks on case processing activities to maintain high standards.
- Process Improvement: Assist in developing and implementing process improvements.
- Training: Participate in training sessions to stay updated on regulatory changes and industry best practices.
- R&D Support: Contribute to research and development initiatives by providing valuable PV insights.
- Issue Resolution: Support the team in handling complex cases and resolving issues effectively.
- Regulatory Knowledge: Maintain up-to-date knowledge of pharmacovigilance regulations and guidelines.
- Communication: Ensure clear and effective communication with stakeholders regarding PV processes.
Qualifications:
- Experience: Minimum of 2 to 3 years of relevant experience in PV case processing.
- Technical Skills: Strong proficiency in MS Excel for data analysis and reporting.
- Knowledge: Solid understanding of PV case processing and regulatory requirements.
- Attention to Detail: Excellent accuracy in data entry and case processing.
- Organizational Skills: Strong organizational and time management abilities.
- Communication: Effective communication and collaboration skills.
- Proactive Approach: Demonstrated problem-solving skills and a proactive approach to process improvement.
- Industry Awareness: Stay current with industry trends and regulatory changes.
- Independence and Teamwork: Ability to work both independently and as part of a team.
- Commitment: Dedication to maintaining high-quality standards in all tasks.
- Education: Relevant degree in life sciences or a related field.
Certifications Required:
- Certified Pharmacovigilance Professional (CPP) or equivalent certification in Pharmacovigilance.
The Cognizant Community:
We are a high-caliber team that supports and appreciates one another. At Cognizant, we foster an energetic, collaborative, and inclusive workplace where everyone can thrive. With over 350,000 associates globally, we are committed to innovation and creating an environment where you can build a successful career path.
About Us:
Cognizant (Nasdaq-100: CTSH) is a leading global professional services company that helps organizations modernize technology, reimagine processes, and transform experiences to stay ahead in a fast-changing world.
Our Commitment to Diversity and Inclusion:
Cognizant is an equal opportunity employer that values diversity, equity, and inclusion. We are dedicated to fostering a community where everyone feels heard, accepted, and welcome. We evaluate candidates based on their qualifications and experience without regard to race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status, or any other protected characteristic.
Accommodation:
If you require reasonable accommodation to search for a job or submit an application due to a disability, please email CareersNA2@cognizant.com with your request and contact information.
Disclaimer:
Compensation information is accurate as of the date of this posting and may be adjusted as necessary. Applicants may be required to attend interviews in person or via video conference and may need to present a government-issued ID during each interview.
