Join AstraZeneca in Bangalore: Shape the Future of Biopharmaceuticals!
Summary: AstraZeneca, a global leader in biopharmaceutical innovation, is seeking talented and dedicated individuals to join our team in Bangalore. We have exciting opportunities across Statistical Programming and Pharmacovigilance, where you will play a vital role in ensuring the safety, compliance, and quality of our clinical data and processes. If you are passionate about making a difference in patient lives and are looking for a challenging and rewarding career, we encourage you to apply!
Available Positions:
We are currently hiring for the following positions in Bangalore:
- Statistical Programmer II (AstraZeneca / Alexion)
- Local Case Intake Advisor (PV – Japan Market)
- Japan Local Case Advisor – GBS Patient Safety
1. Statistical Programmer II – AstraZeneca (Alexion)
Location: Bangalore
Experience: 2–4 years
Work Mode: Hybrid (minimum 3 days/week in office)
About the Role:
As a Statistical Programmer II, you will be responsible for developing and validating SDTM, ADaM datasets, and TLFs, supporting programming specifications, ensuring compliance with CDISC/ICH guidelines and GCP, and collaborating with cross-functional teams. This is a hybrid role requiring a minimum of 3 days per week in the office.
Key Responsibilities:
- Develop and validate SDTM, ADaM datasets, and TLFs according to industry standards.
- Support the creation of programming specifications under the guidance of senior programmers.
- Ensure adherence to CDISC/ICH guidelines and GCP compliance in all programming activities.
- Independently manage moderate-scope programming tasks, delivering high-quality results.
- Collaborate effectively with cross-functional teams and external vendors to achieve project goals.
- Contribute to the improvement of SOPs and the development of quality deliverables.
- Continuously build SAS programming proficiency and deepen understanding of study team objectives.
Qualifications:
- 2–4 years of hands-on statistical programming experience in the pharmaceutical, biotechnology, or CRO industry.
- Proficiency in SAS/Base, SAS/Macro, and SAS/STAT programming languages.
- A strong understanding of SDTM/ADaM standards, relational databases, and GCP principles.
- Excellent communication and problem-solving skills.
- Bachelor’s degree in Statistics, Computer Science, or a related field.
Salary (Estimated): INR 9–16 LPA
2. Local Case Intake Advisor – Japan Market (Bangalore)
Location: Bangalore
Experience: 1–2 years
Skill Requirement: Japanese Language Proficiency (JLPT N2/N3)
About the Role:
As a Local Case Intake Advisor, you will be responsible for processing and validating safety cases for the Japanese market, ensuring accurate data entry in ARGUS, and maintaining compliance with PMDA regulations.
Key Responsibilities:
- Process and validate safety cases specifically for the Japanese market, ensuring accuracy and completeness.
- Perform accurate and timely data entry into the ARGUS safety database.
- Follow up with relevant stakeholders to ensure case completeness and resolve any data discrepancies.
- Conduct in-line Quality Control (QC) for clinical trial safety cases to maintain data integrity.
- Maintain audit readiness by adhering to PMDA regulations and internal SOPs.
- Identify potential compliance gaps and actively support the Corrective and Preventive Action (CAPA) process.
- Collaborate effectively with regulatory affairs, medical information, and quality teams to ensure seamless safety case management.
Qualifications:
- Bachelor’s degree in Life Science, Pharmacy, or a related Medical field.
- JLPT N2 certification is required. JLPT N3 certification may be considered with relevant Pharmacovigilance experience.
- Knowledge of Pharmacovigilance (PV) principles, Good Pharmacovigilance Practices (GVP/GCP), and MedDRA coding is preferred.
- Excellent communication skills, both written and verbal, are essential.
- Strong attention to detail and a commitment to accuracy.
Salary (Estimated): INR 5–10 LPA
3. Japan Local Case Advisor – GBS Patient Safety
Location: Bangalore
Experience: 1–2 years
Japanese Proficiency: N2 or higher
About the Role:
As a Japan Local Case Advisor, you will be responsible for managing safety cases originating from Japan, ensuring compliance with Japanese PV laws, and supporting regulatory audits.
Key Responsibilities:
- Accept, assess, and triage safety cases originating from Japan, prioritizing based on severity and regulatory requirements.
- Handle confidential patient information with the utmost care and in compliance with Japanese Pharmacovigilance (PV) laws.
- Perform accurate and timely data entry for both domestic and foreign safety cases in the appropriate databases.
- Support regulatory audits and maintain inspection readiness by adhering to internal SOPs and external regulations.
- Maintain compliance with the Quality Management System (QMS) and proactively track changes in PV regulations.
- Participate in Pharmacovigilance (PV) projects and conduct peer reviews to ensure continuous improvement in safety processes.
Qualifications:
- Bachelor’s degree in Pharmacy, Life Science, or a related Medical field is preferred.
- Prior experience in Pharmacovigilance (PV) data entry, with knowledge of the ARGUS safety database, is highly desirable.
- Demonstrated high attention to detail and a proactive problem-solving mindset.
- Familiarity with MedDRA and WHO-DD coding is an advantage.
Salary (Estimated): INR 6–12 LPA
Why Join AstraZeneca?
- Impactful Work: Work with global teams and contribute to improving patient safety worldwide.
- Global Exposure: Gain exposure to Japan’s regulatory and Pharmacovigilance (PV) systems.
- Growth-Oriented Culture: Thrive in a hybrid work environment that promotes professional growth and development.
- Upskilling Opportunities: Access opportunities for continuous learning and career advancement.
- Inclusive Environment: Be part of a diverse and inclusive organization that values every individual.
How to Apply
If you are a motivated and skilled professional looking for a challenging and rewarding career, we encourage you to apply!
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We look forward to receiving your application!