Lit FTA (Full Text Article) Review Advisor

Overview What you'll do Success profile Responsibilities Reasons to join Benefits SEARCH JOBS Lit FTA (Full Text Article) Review Advisor Posted date Mar. 10, 2026 Contract type Full time Job ID R-247377 APPLY NOW 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. 0% 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. 0% 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. 0% 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. 0% 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-247377 Date posted 03/10/2026 Job Title: Lit FTA (Full Text Article) Review Advisor Career Level: C Introduction to role: Are you ready to turn complex literature and safety data into timely, compliant regulatory submissions that protect patients and strengthen trust? In this role, you will be a key partner enabling our teams to move faster and deliver with confidence—translating evidence into action that stands up to inspection. You will work at the intersection of science, regulation, and enterprise performance, guiding how we capture, assess, and report safety information across markets. Can you see yourself orchestrating literature surveillance, reportability decisions, and submissions that consistently meet global standards? Your impact will be felt in every compliant report, every audit-ready trail, and every patient protected. Accountabilities: Regulatory Documentation & Submissions Prepare, review, and submit regulatory reports, ensuring the complete, accuracy, and compliance within legal requirements Maintain documentation for regulatory audits and inspections Collaborate with cross-functional teams (e.g. Quality Assurance, Medical Affairs, Client PS Teams) to ensure alignment on regulatory reporting requirements Evaluate literature citations to confirm relevance, accuracy, and completeness of safety-related content. Perform literature case reconciliation to ensure all cited articles, abstracts, and publications are reviewed and matched correctly with internal safety case listings. Retrieve and procure full‑text articles from approved sources, libraries, databases, publishers, journal subscriptions, and open-access platforms. Regulatory Reporting Compliance Assess each Literature article to determine regulatory reportability in alignment with FDA guidelines and company SOPs. Ensure timely and accurate submission of regulatory reports, including Adverse Event Reports, Periodic Safety Update Reports and other required documentation Interpret and apply global regulatory reporting requirements including those for health authorities Monitor updates to regulatory guidelines and ensure internal GBS processes align with evolving reporting standards Adverse Event and Safety Reporting Coordinate pharmacovigilance reporting activities, ensuring compliance with Good Pharmacovigilance Practices Work closely with safety teams to assess, process, and submit Individual Case Safety Reports within required timescales Assist in detection and risk assessment activities to client safety protocols General Actively contribute to maintaining the core components of Good Pharmacovigilance Practice, via contribution to all safety related processes and brand activities within countries of remit and being audit and inspection ready. Support external service providers to meet the company and local regulatory PV requirements. Complete all required patient safety trainings in adherence to internal processes and external regulations, and obtain access to relevant systems, such as Safety Database, Regulatory systems, Human Resources systems, Quality Management Systems, and other global or local systems commercial databases as appropriate. Maintain current and in-depth knowledge of: Relevant country regulatory authority regulations Global and local procedural and guidance documents Conditions, obligations and other commitments relating to product safety or the safe use of AZ products Maintain accurate documentation, audit trails, and version control for all reviewed literature Essential Skills/Experience: Bachelor's degree in pharmacy, Life Sciences, Regulatory Affairs, or a related field 3 years + of experience in regulatory affairs, pharmacovigilance or regulatory reporting in the pharmaceutical industry Pharmacovigilance knowledge excellence including literature analysis Good Pharmacovigilance Practice Knowledge of health authority’s regulations Cross functional collaborative approach Effective and lateral thinking Problem solving Vendor management Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: PV Regulatory Reporting experience Medical knowledge in company Therapeutic Areas Successful participation in above-market projects Audit & Inspection experience When we put unexpected teams in the same room, we fuel 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. Why AstraZeneca: Here, your expertise powers the enterprise—bringing together a diverse set of minds to solve complex problems and accelerate how we safeguard patients. You will work with colleagues who challenge assumptions, share knowledge generously, and embrace exciting technologies to reimagine our processes. We value kindness alongside ambition, and we back curiosity with real investment in learning, so you can grow your impact while helping us move faster, make better decisions, and deliver safety insights that matter. Bring your regulatory reporting expertise to a team where your work protects patients and elevates performance—step forward and make your impact today! Date Posted 13-Mar-2026 Closing Date 12-Mar-2026 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. APPLY NOW Explore the local area Take a look at the map to see what’s nearby. Reasons to Join Thomas Mathisen Sales Representative Oslo, Norway Christine Recchio Sales Representative California, United States Stephanie Ling Sales Representative Petaling Jaya, Malaysia 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. Join our Talent Network Be the first to receive job updates and news from AstraZeneca SIGN UP About Us We are AstraZeneca, one of the world’s most forward-thinking and connected BioPharmaceutical companies. Explore our world. Life at AstraZeneca At AstraZeneca, our purpose is to help patients all over the world by delivering life-changing medicines as one collaborative team. Inclusion & Diversity The success of AstraZeneca is founded on innovation, creativity and diversity. Discover what this means for you. Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value our people. SEE OUR LATEST GLASSDOOR REVIEWS HERE