Job Summary
We are seeking an experienced professional for the role of TL-Pharmacovigilance with 6 to 9 years of experience. The ideal candidate will have expertise in Pharma Research & Development and proficiency in MS Excel. Experience in PV Case Processing and Pharmacovigilance & Safety Ops is a plus. The role involves a hybrid work model with rotational shifts.
Responsibilities
- Oversee the pharmacovigilance activities to ensure compliance with regulatory requirements and company standards.
- Provide expertise in Pharma Research & Development to enhance the quality and efficiency of safety operations.
- Utilize MS Excel to analyze and report pharmacovigilance data accurately and efficiently.
- Coordinate with cross-functional teams to ensure seamless integration of safety data into the overall drug development process.
- Monitor and evaluate adverse event reports to identify potential safety signals and trends.
- Ensure timely and accurate case processing in accordance with standard operating procedures.
- Collaborate with global teams to harmonize pharmacovigilance practices and share best practices.
- Develop and implement safety monitoring plans to proactively manage potential risks.
- Conduct regular audits and assessments to ensure compliance with pharmacovigilance regulations.
- Provide training and guidance to junior staff on pharmacovigilance processes and procedures.
- Support the preparation of safety reports and regulatory submissions.
- Engage in continuous improvement initiatives to enhance pharmacovigilance operations.
- Maintain up-to-date knowledge of pharmacovigilance regulations and industry trends.
Qualifications
- Demonstrate strong expertise in Pharma Research & Development with a focus on safety operations.
- Exhibit proficiency in MS Excel for data analysis and reporting.
- Possess experience in PV Case Processing and Pharmacovigilance & Safety Ops as a valuable asset.
- Show ability to work effectively in a hybrid work model with rotational shifts.
- Display excellent communication and collaboration skills to work with cross-functional teams.
- Have a keen eye for detail and a proactive approach to identifying and managing risks.
Certifications Required
Certified Pharmacovigilance Professional (CPP) or equivalent certification preferred.
The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.
- Cognizant is a global community with more than 300,000+ associates around the world.
- We don’t just dream of a better way – we make it happen.
- We take care of our people, clients, company, communities and climate by doing what’s right.
- We foster an innovative environment where you can build the career path that’s right for you.
About us:
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, building the bridge between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, realize tangible returns and keep global enterprises ahead in a fast-changing world. See how at www.cognizant.com or @cognizant.
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
Disclaimer:
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.