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Associate Director, Senior Patient Safety Scientist

Posted date Dec. 16, 2024
Contract type Full time
Job ID R-215392
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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 ID R-215392 Date posted 12/16/2024

Job Title - Associate Director, Senior Patient Safety Scientist

Career Level -E

Introduction to role

Are you ready to lead the charge in ensuring patient safety and making a real difference? As an Associate Director, Senior Patient Safety Scientist, you will spearhead the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and Patient Safety Scientist. You will author and lead PV input to safety documents and regulatory reports, lead meetings, and present safety data and analyses. Join us in our mission to deliver life-changing medicines to patients worldwide

Accountabilities

  • Lead and/or conduct proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.

  • Lead PS activities of cross-functional project teams for marketed products and/or developmental compounds.

  • Provide safety expertise to Investigator Brochures and Protocols, Informed Consents, and Clinical Study Reports.

  • Perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects.

  • Present complex issues to the Safety Information Review Committee (SIRC) and take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP, and other key stakeholders.

  • Collaborate with GSP and Clinical representatives to author the Reference Safety Information (RSI) for multiple or complex marketed products and/or development products.

  • Author/provide strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.

  • Participate in negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.

  • Train and mentor junior members of the team in approved PV processes, analytic methodologies, etc.

  • Author/provide strategic leadership to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.

Essential Skills/Experience

  • Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development

  • Comprehensive understanding of applicable Patient Safety regulatory obligations

  • Awareness of Patient Safety policies, processes, and procedures

  • Awareness of medico-legal aspects of patient safety

  • 11 to 13 years Patient Safety experience (Pharmacovigilance)

  • Total of 14 to 16 years of experience

Desirable Skills/Experience

  • Well-developed interpersonal skills

  • Cultural sensitivity

  • Ability to network with other functions globally

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 are committed to reimagining how we work by finding solutions to operate more efficiently on a global scale. Our entrepreneurial approach challenges the status quo and takes calculated risks to transform processes through simplification, automation, and data analytics. We are a trusted partner to the business, driving new ways of working and innovative solutions while ensuring that automation and data are at the heart of everything we do. Join us on our journey of growth and evolution as we strive to make a difference for patients worldwide.

Ready to make an impact? Apply now!

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.

50056681 E CDSU

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.

Sales Representative Oslo, Norway

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.

Sales Representative California, United States

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.

Sales Representative Petaling Jaya, Malaysia

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.

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.