Job Title: Local Case Intake Advisor – GBS Patient Safety
Company: AstraZeneca
Location: Bengaluru, India
Job Type: Full-Time
Career Level: C
Job ID: R-247617
Experience Required: Typically 2–5 Years in Pharmacovigilance or Drug Safety
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. With a strong commitment to advancing healthcare, AstraZeneca delivers life-changing therapies across multiple therapeutic areas including oncology, cardiovascular, respiratory, immunology, and rare diseases. The company combines cutting-edge science with advanced digital technologies to accelerate medical innovation and improve patient outcomes worldwide.
Role Overview
AstraZeneca is seeking a Local Case Intake Advisor – GBS Patient Safety to support pharmacovigilance operations and safety case intake activities at the local level. The role focuses on the management, intake, and processing of Individual Case Safety Reports (ICSRs) while ensuring compliance with AstraZeneca policies and national regulatory requirements. The selected candidate will act as a key liaison between local Marketing Companies and the Global Business Services – Patient Safety (GBS-PS) team, ensuring timely and compliant adverse event reporting.
Key Responsibilities
ICSR Intake and Pharmacovigilance Operations
Manage the intake, processing, and reporting of Individual Case Safety Reports (ICSRs) from local marketing companies.
Support the handling of adverse event reports originating from clinical studies, post-marketing sources, and spontaneous reports related to AstraZeneca products.
Ensure accurate case intake processes aligned with global pharmacovigilance standards and regulatory requirements.
Regulatory Compliance and Health Authority Interaction
Ensure compliance with global pharmacovigilance guidelines and national health authority regulations.
Support responses to safety-related queries from health authorities.
Contribute to maintaining regulatory compliance in patient safety reporting processes.
Quality Management and Documentation
Support the operational implementation of the Pharmacovigilance Quality Management System (QMS).
Maintain procedural documentation related to pharmacovigilance processes and safety reporting.
Assist with adverse event and pharmacovigilance training requirements within the organization.
Support audit readiness activities and report quality incidents where applicable.
Cross-Functional Collaboration
Act as a primary contact between local marketing companies and the GBS Patient Safety team.
Collaborate with internal teams and external partners to support pharmacovigilance activities.
Contribute to pharmacovigilance aspects related to organized data collection programs, digital channels, and social media monitoring.
Risk Management and Safety Expertise
Provide patient safety expertise to local marketing companies.
Support risk management activities, safety issue management, and action plan development for key products.
Participate in local projects that support pharmacovigilance operations and patient safety initiatives.
Educational Qualifications
Bachelor’s or Master’s degree in Pharmacy, Medicine, Life Sciences, or a related scientific discipline.
Experience Requirements
Typically 2–5 years of experience in pharmacovigilance, drug safety, or related pharmaceutical roles.
Practical experience in adverse event reporting and ICSR management is preferred.
Required Skills and Competencies
Strong understanding of pharmacovigilance principles and Good Pharmacovigilance Practices (GVP).
Knowledge of global and national health authority regulations related to drug safety reporting.
Excellent analytical and problem-solving abilities.
Strong cross-functional collaboration and stakeholder management skills.
High attention to detail and documentation accuracy.
Excellent written and verbal communication skills.
Preferred Skills
Experience in project management and cross-regional pharmacovigilance initiatives.
Knowledge of therapeutic areas relevant to AstraZeneca products.
Experience supporting audits or regulatory inspections.
Strong influencing and conflict resolution skills.
Work Environment
This role follows a hybrid working model, with employees expected to work from the office at least three days per week while maintaining flexibility to support collaboration and operational efficiency.
Why Join AstraZeneca
At AstraZeneca, employees contribute to developing innovative therapies that improve and save lives worldwide. The organization fosters a culture of scientific excellence, collaboration, and continuous innovation, empowering professionals to make meaningful contributions to patient safety and healthcare advancement.
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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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Norway | NOrway |Romania :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
North York | Mississauga | Richmond Hill | Uxbridge | Renfrew | Australia |Canada :
Canada |Quebec :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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