Job Title: Regulatory Reporting Advisor – Patient Safety
Company: AstraZeneca
Location: Bengaluru, India
Job Type: Full-Time
Career Level: C
Job ID: R-247377
Experience Required: Minimum 3+ Years
About AstraZeneca
AstraZeneca is a global, science-driven biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that transform patient care. With strong expertise across therapeutic areas including oncology, cardiovascular, respiratory, and immunology, AstraZeneca integrates advanced science, digital technologies, and global collaboration to improve health outcomes worldwide. The organization is committed to maintaining the highest standards of patient safety, regulatory compliance, and scientific excellence.
Role Overview
AstraZeneca is seeking a Regulatory Reporting Advisor – Patient Safety to support pharmacovigilance and regulatory reporting operations. In this role, you will contribute to the preparation, review, and submission of regulatory safety reports while ensuring compliance with global regulatory requirements and Good Pharmacovigilance Practices (GVP). The position requires expertise in literature surveillance, adverse event reporting, and regulatory documentation to ensure patient safety data is captured, assessed, and reported accurately across global markets.
Key Responsibilities
Regulatory Documentation and Safety Reporting
Prepare, review, and submit regulatory safety reports ensuring accuracy, completeness, and compliance with regulatory requirements.
Maintain regulatory documentation and ensure readiness for audits and inspections.
Collaborate with internal teams including Quality Assurance, Medical Affairs, and Patient Safety teams to align regulatory reporting activities.
Literature Surveillance and Safety Data Management
Evaluate scientific literature citations to ensure relevance and accuracy of safety-related information.
Conduct literature case reconciliation to confirm that articles, abstracts, and publications correspond with internal safety case records.
Retrieve and review full-text scientific publications from approved databases, journals, and academic resources.
Regulatory Reporting Compliance
Assess literature articles and safety information to determine regulatory reportability according to FDA guidelines and internal SOPs.
Ensure timely submission of regulatory safety reports such as Adverse Event Reports and Periodic Safety Update Reports.
Interpret global pharmacovigilance regulations and health authority requirements for safety reporting.
Monitor regulatory guideline updates and ensure alignment with internal processes and compliance frameworks.
Adverse Event and Pharmacovigilance Operations
Coordinate pharmacovigilance reporting activities in accordance with Good Pharmacovigilance Practices.
Support the assessment, processing, and submission of Individual Case Safety Reports within regulatory timelines.
Assist with signal detection activities and safety risk assessments in collaboration with pharmacovigilance teams.
Quality, Compliance, and Process Management
Contribute to maintaining the organization’s pharmacovigilance quality systems and regulatory compliance processes.
Ensure accurate documentation, version control, and audit trails for all safety-related documentation and literature reviews.
Maintain up-to-date knowledge of global and country-specific pharmacovigilance regulations and regulatory commitments.
Operational Support and Training
Support external vendors and service providers in meeting pharmacovigilance regulatory requirements.
Complete mandatory patient safety training and ensure compliance with internal procedures and global regulatory systems.
Utilize safety databases, regulatory reporting platforms, quality management systems, and other operational tools.
Educational Qualifications
Bachelor’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related scientific discipline.
Experience Requirements
Minimum 3+ years of experience in regulatory affairs, pharmacovigilance, regulatory reporting, or drug safety within the pharmaceutical industry.
Experience in literature analysis and safety reporting processes is preferred.
Required Skills and Competencies
Strong knowledge of pharmacovigilance principles and Good Pharmacovigilance Practices (GVP).
Understanding of global regulatory reporting requirements and health authority regulations.
Experience in literature surveillance, safety case reconciliation, and regulatory documentation.
Excellent analytical thinking and problem-solving abilities.
Strong cross-functional collaboration and stakeholder management skills.
High attention to detail and strong documentation accuracy.
Excellent written and verbal communication skills.
Preferred Skills
Experience in pharmacovigilance regulatory reporting processes.
Knowledge of therapeutic areas relevant to AstraZeneca products.
Experience participating in global or multi-market regulatory projects.
Exposure to regulatory audits and inspections.
Work Environment
This role typically follows a hybrid work model, where employees are expected to work from the office several days per week while maintaining flexibility to support collaboration and project requirements.
Why Join AstraZeneca
Working at AstraZeneca offers the opportunity to contribute directly to patient safety and global healthcare innovation. Employees collaborate with leading experts across science, technology, and regulatory affairs to ensure medicines are safe, effective, and compliant with international standards. The organization fosters continuous learning, innovation, and professional growth within a collaborative global environment.
Job Location
Bengaluru, India.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Peru | Argentina |Brazil :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
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Paris | Lyon |South Africa :
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