Senior Drug Safety Physician Job at Indegene in Karnataka focusing on pharmacovigilance, case processing, MedDRA coding, and global safety compliance.
Introduction
The healthcare and life sciences industry is rapidly evolving with the integration of advanced technologies, data-driven insights, and patient-centric safety frameworks. Among the most critical domains in this ecosystem is pharmacovigilance and drug safety, which ensures that medicinal products are monitored continuously for safety, efficacy, and regulatory compliance throughout their lifecycle. Senior Drug Safety Physician Job at Indegene
In this context, Indegene, a globally recognized technology-led healthcare solutions provider, is inviting applications for the role of Senior Drug Safety Physician. This position offers a unique opportunity to work at the intersection of healthcare, medical science, and technology while contributing meaningfully to patient safety and regulatory excellence.
This role is based in Karnataka, India, and is ideal for experienced drug safety professionals who possess a strong understanding of case processing, regulatory requirements, medical coding, and global pharmacovigilance standards. Senior Drug Safety Physician Job at Indegene
About Indegene
Indegene is driven by a powerful purpose: to enable healthcare organizations to be future-ready. With a strong global presence and a culture that fosters innovation, collaboration, and empathy, the company delivers end-to-end healthcare solutions powered by technology, analytics, and deep domain expertise.
At Indegene, careers are not just about roles; they are about long-term professional journeys. Employees are encouraged to think entrepreneurially, act boldly, and grow alongside the organization’s rapid global expansion. The company strongly believes in mentoring talent, nurturing leadership capabilities, and providing accelerated growth opportunities in the healthcare and life sciences domain. Senior Drug Safety Physician Job at Indegene
Position Overview: Senior Drug Safety Physician
Job Title: Senior Drug Safety Physician
Location: Karnataka (KA), India
Date Posted: 15 December 2025
Employment Type: Full-Time
Functional Area: Pharmacovigilance / Drug Safety
As a Senior Drug Safety Physician, you will play a vital role in ensuring accurate and compliant processing of individual case safety reports (ICSRs). You will contribute directly to patient safety by reviewing adverse event data, performing medical assessments, and supporting regulatory reporting obligations across global markets. Senior Drug Safety Physician Job at Indegene
This role demands strong medical knowledge, attention to detail, and a clear understanding of drug safety regulations, making it ideal for professionals with experience in pharmacovigilance operations and clinical safety. Senior Drug Safety Physician Job at Indegene
🔹 Key Highlights (Quick Overview)
Job Role: Senior Drug Safety Physician
Industry: Healthcare Technology & Pharmacovigilance
Core Expertise: Case processing, MedDRA coding, narratives, regulatory reporting
Work Location: Karnataka, India
Career Growth: Global exposure, fast-track career progression
Work Culture: Inclusive, innovation-driven, collaborative
Employer Type: Equal Opportunity Employer
Key Roles and Responsibilities
The Senior Drug Safety Physician will be responsible for managing end-to-end safety case processing activities with accuracy, consistency, and regulatory compliance. Key responsibilities include: Senior Drug Safety Physician Job at Indegene
Case Intake and Validation
- Confirm the validity of safety cases by identifying the minimum required criteria for case creation.
- Perform duplicate searches to determine whether a case should be processed as an initial report or a follow-up.
- Ensure correct classification of cases based on seriousness, expectedness, and regulatory definitions.
Pharmacovigilance Case Handling
- Apply a strong understanding of patient safety case-handling processes, including global regulatory requirements for Individual Case Safety Reports (ICSRs).
- Identify and manage serious adverse events, medically significant events, and special scenarios.
- Handle special cases such as lack of efficacy, pregnancy exposure, overdose, misuse, medication errors, at-risk cases, and product quality complaints.
Documentation and Follow-Up
- Attach all relevant source documents, including medical records, safety queries, follow-up information, and supporting evidence.
- Initiate and facilitate follow-up activities based on queries raised by data entry teams, quality control reviewers, medical reviewers, or due to missing or inconsistent source information.
- Ensure completeness, accuracy, and traceability of safety documentation.
Medical Coding and Data Quality
- Perform accurate medical coding for adverse events, medical history, laboratory data, and indications using standardized dictionaries such as MedDRA.
- Code drug products appropriately, including suspect, co-suspect, and concomitant medications, in line with client conventions and regulatory expectations.
- Maintain high data quality standards to support downstream regulatory submissions and signal detection activities.
Narrative Writing and Medical Review
- Draft clear, concise, and medically sound case narratives that accurately reflect the clinical course and safety assessment.
- Apply medical judgment during case review to assess seriousness, causality, and clinical relevance.
- Support internal and external audits by ensuring compliance with standard operating procedures (SOPs).
Your Impact in This Role
As a Senior Drug Safety Physician, your work will directly influence patient safety outcomes and regulatory decision-making. By ensuring high-quality safety data, you will support pharmaceutical companies, healthcare organizations, and regulators in making informed risk-benefit assessments. Senior Drug Safety Physician Job at Indegene
Your expertise will contribute to:
- Improved safety surveillance processes
- Enhanced regulatory compliance
- Better patient outcomes worldwide
- Strengthening Indegene’s reputation as a trusted healthcare solutions partner
Required Skills and Qualifications (Must Have)
Candidates applying for this role should meet the following requirements: Senior Drug Safety Physician Job at Indegene
Core Knowledge and Expertise
- Strong understanding of drug safety and pharmacovigilance case-handling processes.
- Familiarity with the overall drug development and drug research lifecycle.
- Knowledge of global regulatory guidelines related to adverse event reporting.
Cognitive and Analytical Skills
- Excellent attention to detail and accuracy in data handling.
- Strong critical and analytical thinking abilities.
- Ability to evaluate clinical information and apply sound medical judgment.
Medical and Technical Skills
- Good knowledge of medical terminology and therapy areas.
- Hands-on experience with MedDRA coding and safety databases.
- Ability to interpret laboratory data, clinical narratives, and medical records.
Communication Skills
- Strong verbal and written communication skills in English.
- Ability to collaborate effectively with cross-functional teams.
- Professional interpersonal skills for internal and external stakeholder interactions.
Good to Have (Additional Skills)
While not mandatory, the following skills are considered an added advantage: Senior Drug Safety Physician Job at Indegene
- Prior experience working in global pharmacovigilance operations.
- Exposure to multiple regulatory regions such as US FDA, EMA, MHRA, or other health authorities.
- Experience in audit support, inspections, or process improvement initiatives.
- Familiarity with safety databases and PV tools.
Career Growth and Work Culture
Indegene offers a differentiated career experience, particularly for professionals in the early and mid-stages of their careers. Employees benefit from: Senior Drug Safety Physician Job at Indegene
- Structured mentoring by industry experts.
- Exposure to global clients and healthcare markets.
- Opportunities to work at the convergence of healthcare and digital technology.
- A culture that values innovation, empathy, and collaboration.
The organization promotes agility, accountability, and continuous learning, enabling professionals to grow alongside its high-speed global expansion.
Equal Opportunity Employer Statement
Indegene is committed to fostering a diverse, inclusive, and equitable workplace. The company does not discriminate on the basis of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, gender identity, veteran status, or any other legally protected characteristic.
All employment decisions are made based on business needs, candidate merit, and qualifications, ensuring fairness and transparency throughout the hiring process. Senior Drug Safety Physician Job at Indegene
How to Apply
Interested and eligible candidates can apply online through Indegene’s official careers portal. Senior Drug Safety Physician Job at Indegene
Application Steps:
- Visit the official Indegene careers website.
- Search for the job title Senior Drug Safety Physician.
- Select the relevant job posting for Karnataka, India.
- Complete the online application form with accurate personal and professional details.
- Upload your updated resume highlighting pharmacovigilance and drug safety experience.
- Submit the application and monitor your email for further communication from the recruitment team.
Candidates are advised to apply at the earliest, as positions may close once suitable applicants are identified. Senior Drug Safety Physician Job at Indegene
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
