Why choose AstraZeneca India?
Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare.
The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports.
Who do we look for?
Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.
Success Profile
Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.
Tech innovators
Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives.
Ownership takers
If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it.
Challenge seekers
Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks.
Proactive collaborators
Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best.
Responsibilities
Job Title - Associate Director Patient Safety Systems
Career Level - E
Introduction to role
Join our team at AstraZeneca as an Associate Director of Patient Safety Systems within Global Patient Safety Technology Solutions. In this role, you will be responsible for the governance, maintenance, and enhancement of systems owned by Global Patient Safety (GPS). These systems are crucial for meeting our pharmacovigilance, regulatory, and legal obligations. You will ensure that our pharmacovigilance systems, safety surveillance systems, and other GPS-owned systems are effectively maintained, developed, and supported to meet business needs while adhering to all relevant regulations.
Accountabilities
Responsible for ensuring that GxP regulatory compliance requirements on GPS-owned computerized systems that support GxP regulated business processes are understood and met.
Responsible for Quality Management oversight of computerized systems owned by GPS, ensuring the GxP requirements are taken into account, and that the necessary validation documents exist, and that they are clear, complete and retrievable.
Provision of Quality Management expertise in respect of GPS-owned systems, ensuring that they continue to meet all relevant GxP requirements, as well as all quality standards, in respect of validation documentation.
Maintains an overview of the GPS system estate, from a QM perspective, as well as a rolling ‘high-level’ view of system change.
Approval of the Regulatory Impact Determination (RID) for all GPS-owned systems, and provision of expertise into the generation of the RID, to determine whether or not a system has potential GxP impact and needs to be validated. Participation in Privacy Impact Assessment and eDiscovery assessment as part of the RID.
Review and approval of User Requirements Specification for all GPS-owned systems, ensuring that any requirements which relate to GxP, or which could impact patient safety, product quality, or records required to be created and maintained in support of GxP, are included and clearly identified as GxP within the URS.
Responsible for providing input to the high-level risk assessment process to ensure that risks relating to GxP impact are included and managed.
Review and approval of the Validation Plan for all GPS-owned systems, ensuring the activities planned are appropriate to address the GxP requirements. Approval of the User Acceptance testing.
Responsible for signing off all GPS-owned systems into use via approval of the Validation Report, which must provide sufficient evidence to support the compliance status of the system.
Participates in project audits, quality management reviews and inspections as necessary, providing an independent ‘quality’ voice.
Contributes to the overall quality of GPS-owned systems by working closely with the business and R&D IT teams responsible for maintenance and upgrade of those systems.
Ensuring overall system quality through early deviation detection and risk reduction.
Maintains a robust and ‘up to date’ knowledge of all internal and external regulations pertaining to computer system validation, with particular emphasis on GxP processes, providing appropriate recommendations for change as necessary.
Maintains a close working relationship with the R&D IT Quality Manager and Business Project Manager on each project, ensuring they fully understand the areas of potential GxP impact that each project/system may have.
Essential Skills/Experience
Bachelor’s degree or equivalent experience within the pharmaceutical or IT industries.
Experience of computer system validation in a regulated environment, preferably the pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc., and knowledge of regulatory (GxP, SOX etc.) requirements for computerized systems and infrastructure.
Good understanding of current system development lifecycle methodologies.
Proven skills in formulating an independent and objective recommendation.
Experience of how to determine, reach and maintain acceptable quality levels.
Experience of performing, reviewing and approving risk assessments.
Clear evidence of organizational skills.
Desirable Skills/Experience
Ability to proactively identify potential compliance issues and subsequently advise on their avoidance/resolution/remediation.
In-depth knowledge of current developments in the pharmaceutical industry and global regulatory environment, and their potential impact on regulatory compliance, pharmacovigilance, signal and risk management activities, safety value demonstration and safety science-related activities.
Experience of delivering enhancement projects for a GxP, ER/ES, GVP or other ‘regulated’ system.
Key capability requirements:
Understanding and management of risk
Building relationships across cultures, functions and disciplines
Keen analytic and problem-solving skills
Strong focus on quality
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we thrive in an inclusive environment where curious minds come together. We are committed to making a difference by fusing data and technology with scientific innovations to achieve breakthroughs. Our collaborative approach with academia and biotech expands our horizons and empowers us to be our best.
Ready to make an impact? Apply now to join our team!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Reasons to Join
Thomas Mathisen
There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.
Christine Recchio
Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.
Stephanie Ling
There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.
What we offer
We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you.
Lifelong learning
Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still.
Autonomy and reward
Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package.
Health and wellbeing
An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority.
Inclusion and diversity
Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.