**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 chance 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. Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.