Pharmacovigilance Job at Indegene
Looking for a high-growth pharmacovigilance career with a global healthcare technology company? Indegene is hiring a Senior Drug Safety Physician – Aggregate Reporting for its pharmacovigilance and drug safety team. This Pharmacovigilance Job in Bengaluru is ideal for MBBS, MD, MS, and DNB professionals with experience in medical review and aggregate safety reporting. This role at Indegene Careers offers exposure to global regulatory requirements, signal management, risk-benefit evaluation, and safety surveillance activities. Candidates will work at the intersection of healthcare and technology while contributing to patient safety and regulatory compliance.
About the Company:
Indegene is a technology-led healthcare solutions provider dedicated to helping healthcare organizations become future-ready. The company combines healthcare expertise with advanced technology solutions to drive innovation across the life sciences industry.
With a strong global presence, Indegene provides accelerated growth opportunities for professionals who are ambitious, innovative, and passionate about transforming healthcare. The organization fosters entrepreneurship, collaboration, empathy, and continuous learning while offering employees opportunities to work on impactful global projects.
Job Details:
- Job Title: Senior Drug Safety Physician – Aggregate Reporting
- Industry: Healthcare Technology and Pharmacovigilance
- Department: Drug Safety and Pharmacovigilance
- Employment Type: Full-Time
- Work Area: Pharmacovigilance, Medical Review, Aggregate Reporting, Signal Management
- Work Environment: Global Healthcare and Technology Organization
Key Responsibilities:
- Perform medical review of adverse events, including seriousness, expectedness/listedness, and causality assessments.
- Ensure compliance with pharmacovigilance reporting timelines and quality standards.
- Conduct medical review and oversight of Individual Case Safety Reports (ICSRs).
- Support literature surveillance activities and the preparation of aggregate reports.
- Identify, assess, validate, and monitor potential safety signals.
- Contribute to signal detection activities in accordance with established guidelines and SOPs in this Pharmacovigilance Job in Bengaluru.
- Review and oversee periodic aggregate safety reports, including PBRERs, DSURs, SUSARs, PADERs, PAERs, ACOs, and RMPs.
- Ensure completeness, accuracy, and medical integrity of safety data and reports.
- Participate in pharmacovigilance and risk management planning activities at Indegene Careers.
- Conduct risk-benefit evaluations and provide medical insights for safety deliverables.
- Attend assigned training programs relevant to pharmacovigilance and drug safety.
- Support cost optimization, quality improvement, and reduced project cycle times.
- Collaborate with clients and internal stakeholders to meet project expectations.
Educational Requirements for this Pharmacovigilance Job:
- An MBBS degree from a recognized institution.
- MD, MS, or DNB qualifications are also eligible.
- Candidates should possess relevant experience in pharmacovigilance, hospitals, or pharmacy.
- Minimum 3 years of relevant professional experience required.
- At least 1 year of experience in medical review of aggregate safety reports preferred.
Skills Required:
- Strong knowledge of pharmacovigilance principles and practices.
- Understanding of drug development processes and lifecycle management.
- Knowledge of global regulatory requirements and safety guidelines.
- Experience with regulatory documentation and aggregate safety reports.
- Familiarity with document management systems and safety databases.
- Proficiency in Microsoft Excel, Outlook, and related applications.
- Excellent written and verbal communication skills.
- Strong analytical and clinical assessment capabilities.
- Good organizational and time management skills.
- Attention to detail and sound decision-making abilities.
- Strong interpersonal and stakeholder management skills.
- Mentoring and team collaboration skills.
Benefits of the Pharmacovigilance Job:
- Opportunity to work with a leading global healthcare technology company.
- Exposure to international pharmacovigilance and regulatory environments.
- Fast-track career growth opportunities within a rapidly expanding organization.
- Involvement in high-impact drug safety and risk management projects.
- Opportunity to work at the convergence of healthcare and technology.
- Collaborative and innovation-driven work culture.
- Access to learning, development, and leadership mentoring programs.
- Exposure to global clients and cross-functional teams.
- Inclusive and diverse workplace environment.
- Opportunity to contribute directly to patient safety and healthcare outcomes.
