Associate Director, Pharmacovigilance Processes (Bengaluru, India)
Global Career Level: E
Job Requisition ID: R-222199
Job Type: Full-time
Application Deadline: April 1, 2025
Introduction to Role:
Join AstraZeneca as an Associate Director, Pharmacovigilance Processes, where you will work closely with the PV Processes Manager, Associate Director, and Director. You will manage AstraZeneca projects and processes, ensuring compliance, performance, and inspection readiness. This role involves developing relationships across Patient Safety and other relevant AstraZeneca functions to ensure successful delivery of process strategies and priorities.
Accountabilities:
Identify opportunities to enhance existing processes through knowledge of internal and external environments.
Collaborate with Process Managers, Associate Directors, and Regulatory authorities to develop, monitor, and assess global KPIs.
Lead process updates in Patient Safety, including content updates, addressing comments, and releasing documents.
Serve as an expert in the ECMS tool and related processes.
Support Process Owners with guidance on procedural documents (PD).
Maintain and support the global inspection readiness strategy.
Provide compliance support to regulatory teams and submissions.
Promote a culture of continuous improvement, performance, and innovation.
Manage the lifecycle of nominated processes to ensure business continuity and compliance.
Monitor, analyze, and validate changes in legislation, ensuring compliance.
Participate in GVP, GCP, GRP, and GMP audits/inspections.
Deliver project assignments and provide process training to functional groups.
Essential Skills/Experience:
Science/Pharmacy/Nursing degree with at least 5 years of relevant experience in pharmaceuticals, regulatory, safety, or partnerships.
Experience in cross-functional team collaboration.
Proven leadership in project management.
Deep understanding of regulatory/pharmacovigilance and partnership issues.
Thorough knowledge of the drug development process.
Strong attention to detail and communication skills.
Ability to work across cultures with proven relationship-building skills.
Understanding of AstraZeneca business and processes.
Strong negotiation, conflict management, and interpersonal skills.
Understanding of change management processes.
Desirable Skills/Experience:
MSC/PhD in a scientific field.
Knowledge of evolving regulatory and pharmacovigilance requirements.
Familiarity with AstraZeneca’s external alliances and collaborative projects.
Knowledge of CoE and CMO operating models.
Experience working with third-party suppliers and in global organizations.
Why Join AstraZeneca?
AstraZeneca is committed to Oncology with the ambition to eliminate cancer as a cause of death. We foster an environment of courage, curiosity, and collaboration while driving innovation with cutting-edge science and technology. Join us to build a rewarding career and make a difference in millions of lives.
Application Details:
Date Posted: March 17, 2025
Closing Date: March 31, 2025
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Siliguri |Illinois :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
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