Job Summary
Join our dynamic team as a Pharmacovigilance Analyst in the Pharma Research & Development sector. In this role, you will play a critical part in ensuring the safety and efficacy of pharmaceutical products through the monitoring, evaluation, and analysis of drug safety data. Working closely with cross-functional teams, regulatory authorities, and internal stakeholders, you will support pharmacovigilance activities and contribute to maintaining compliance with global regulatory requirements.
Responsibilities
- Monitor and evaluate adverse event reports to ensure compliance with pharmacovigilance regulations and internal procedures.
- Collaborate with cross-functional teams to analyze, interpret, and communicate safety data effectively.
- Prepare safety reports and support regulatory submissions in accordance with applicable guidelines and timelines.
- Assist in the development, maintenance, and continuous improvement of pharmacovigilance systems and processes.
- Conduct literature reviews and surveillance activities to identify potential safety signals and emerging risks.
- Support PV case processing activities while ensuring data quality, accuracy, and completeness.
- Contribute to risk assessment and safety monitoring activities for pharmaceutical products.
- Maintain accurate documentation and records to support audits, inspections, and regulatory compliance.
- Participate in process improvement initiatives to enhance operational efficiency and effectiveness.
- Stay current with pharmacovigilance regulations, industry trends, and best practices.
Qualifications
- Degree in a relevant scientific discipline such as Life Sciences, Pharmacy, Medicine, Nursing, or a related field.
- Experience in Pharma Research & Development.
- Strong analytical and problem-solving skills with the ability to interpret complex safety data.
- Proficiency in pharmacovigilance data management and safety databases.
- Excellent communication and teamwork skills, with the ability to collaborate across multiple stakeholders.
- Experience in PV Case Processing.
- Certification in Pharmacovigilance or Drug Safety Management is preferred.
- Familiarity with risk management plans, safety assessments, and signal detection activities.
- Up-to-date knowledge of pharmacovigilance regulations, guidelines, and industry standards.
- Ability to mentor and support junior team members.
- Strong attention to detail and commitment to maintaining high-quality standards.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
Work Model
We believe hybrid work is the way forward as we strive to provide flexibility wherever possible. Based on this role's business requirements, this is a hybrid position requiring 2-3 days a week in a Cognizant office in Sao Paulo, BR. Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.
Benefits
- A career in one of the largest and fastest-growing IT services providers worldwide.
- Ongoing support and funding with training and development plans.
- Opportunity to work for leading global companies.
- A diverse, collaborative, and inclusive work environment.
- Highly competitive salary and benefits, including OSDE for you and your primary family group, annual bonus, and more.
Certifications Required
- Certification in Pharmacovigilance or Drug Safety Management (preferred).