Team Lead – Pharmacovigilance
Job Details
Job Title: Team Lead – Pharmacovigilance
Company: Cognizant
Job ID: 00066060691
Location: Mumbai, India
Work Model: Hybrid
Job Category: Technology & Engineering
Shift: Rotational
Experience & Salary
Experience: Minimum 4+ years in Pharmacovigilance with Aggregate (PSUR) Reporting and Safety Operations
Salary: ₹10–16 LPA (Expected market range, based on experience, skills, and interview performance)
Job Summary
Join Cognizant as a Pharmacovigilance Team Lead and contribute to ensuring the safety and efficacy of pharmaceutical products. The role focuses on pharmacovigilance, aggregate reporting, safety data analysis, regulatory compliance, and leading initiatives to strengthen drug safety processes.
Key Responsibilities
Monitor and evaluate adverse event reports to ensure regulatory compliance.
Analyze safety data and identify potential safety signals.
Prepare and submit Aggregate Reports (PSURs) to regulatory authorities.
Support research and development activities related to drug safety.
Improve pharmacovigilance and safety operations processes.
Provide technical guidance and mentoring to team members.
Develop strategies to enhance safety reporting efficiency.
Maintain accurate safety documentation and databases.
Review and implement pharmacovigilance SOPs.
Respond to safety-related queries from internal and external stakeholders.
Drive continuous process improvement initiatives.
Support training and development of pharmacovigilance staff.
Coordinate with regulatory authorities regarding safety reporting requirements.
Eligibility Criteria
Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
Minimum 4 years of experience in Pharmacovigilance.
Hands-on experience in Aggregate (PSUR) Reporting and Safety Operations.
Relevant Pharmacovigilance certification is preferred.
Required Skills
Strong knowledge of Pharmacovigilance and drug safety regulations.
Expertise in Aggregate (PSUR) reporting.
Excellent analytical and safety data interpretation skills.
Strong communication and stakeholder management abilities.
Leadership and team mentoring experience.
Ability to work in a hybrid environment and rotational shifts.
Good understanding of regulatory guidelines and compliance requirements.
Preferred Certification
Certified Pharmacovigilance Professional (CPP) or equivalent certification.
Working Conditions
Hybrid work model.
Rotational shift schedule.
Collaboration with global teams and regulatory authorities.
Opportunity to lead pharmacovigilance initiatives in a dynamic environment.
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