Job Summary
Data - Join our dynamic team as a Pharmacovigilance Specialist where you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products. With a focus on Pharma Research and Development you will contribute to the monitoring and reporting of drug safety data. This hybrid role offers a rotational shift schedule providing flexibility and the opportunity to make a significant impact on public health.
Responsibilities
- Monitor and evaluate adverse event reports to ensure compliance with regulatory requirements and company standards.
- Collaborate with cross-functional teams to analyze safety data and identify potential safety signals.
- Prepare and submit aggregate reports such as PSURs to regulatory authorities in a timely manner.
- Conduct thorough research and development activities to support the safety profile of pharmaceutical products.
- Utilize your expertise in Pharmacovigilance and Safety Operations to enhance drug safety monitoring processes.
- Provide technical guidance and support to team members in the analysis and interpretation of safety data.
- Develop and implement strategies to improve the efficiency and effectiveness of safety reporting systems.
- Ensure accurate documentation and maintenance of safety data in compliance with regulatory guidelines.
- Participate in the development and review of standard operating procedures related to pharmacovigilance activities.
- Collaborate with stakeholders to address safety-related inquiries and provide expert advice.
- Contribute to the continuous improvement of pharmacovigilance processes and systems.
- Support the training and development of team members in pharmacovigilance practices.
- Engage in regular communication with regulatory authorities to ensure alignment on safety reporting requirements.
Qualifications
- Possess a strong background in Pharma Research and Development with a minimum of 4 years of experience.
- Demonstrate expertise in Aggregate (PSUR) reporting and Pharmacovigilance and Safety Operations.
- Exhibit proficiency in analyzing and interpreting complex safety data.
- Display excellent communication and collaboration skills to work effectively in a hybrid work model.
- Show adaptability to rotational shifts and a commitment to maintaining high standards of safety reporting.
- Hold a relevant certification in Pharmacovigilance or a related field.
Certifications Required
Certified Pharmacovigilance Professional (CPP) or equivalent certification.
About Cognizant:
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap 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, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant.
Additional employment information
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.
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.
