Job Description

Job title: Product Owner for PV Systems

• Location Hyderabad
• Job type: Fulltime

About the jobAt Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing \xe2\x80\x9cHealth in Your Hands\xe2\x80\x9d.Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the \xe2\x80\x9cBest Fast-Moving Consumer Healthcare (FMCH) Company In & For the World\xe2\x80\x9d.We strive to act as a force for good by integrating sustainability along our business and employees\xe2\x80\x99 mission and operate responsibly from both a social and environmental point of view.To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.Our TeamAs the CHC Health and Science Global function within the Digital Division, our mission is clear: we are dedicated to revolutionizing healthcare. We act as strategic partners, providing an organization-wide perspective while effectively utilizing available resources. Our primary focus is on enhancing information systems and refining core competencies in R&D, Regulatory, Medical, and Development, all to maximize value for our consumers. Our unwavering commitment to consumer-centric transformation is central to our mission, driving us to improve lives and instigate significant change. By seamlessly merging scientific expertise with consumer insights, we\'re reshaping our approach to research, development, and the delivery of science-driven solutions that positively impact global health. Our dedication to consumer-centric transformation empowers individuals to actively engage in their healthcare journey and fosters a culture of collaboration, co-creation, and the pursuit of ground-breaking scientific achievements through partnerships with consumers.The Product Owner, Pharmacovigilance, is responsible for managing and prioritizing the product backlog, ensuring that the pharmacovigilance systems and processes align with business objectives, regulatory requirements, and customer needs. This role acts as the bridge between the business stakeholders, regulatory authorities, and the development team, facilitating effective communication and decision-makingMain responsibilities:

• Product Vision and Strategy:

• Define and communicate the vision, roadmap, and strategic direction for all the systems within pharmacovigilance space i.e. ArisGlobal\xe2\x80\x99s LifeSphere suite of applications (LSMV, LSRA, LSR, LSSRM), Literature Surveillance system, etc..
• Collaborate with cross-functional teams, including safety, regulatory affairs, and quality assurance, to align product goals with business objectives and regulatory requirements.
• Continuously monitor industry trends, regulatory changes, and customer feedback to identify opportunities for product improvements and enhancements.
• Product Backlog Management:

• Maintain and prioritize the product backlog for the above stated applications, ensuring that user stories and requirements are clearly defined, properly sized, and aligned with the product vision and regulatory requirements.
• Facilitate backlog grooming sessions with the development team and subject matter experts to clarify requirements and ensure a shared understanding.
• Continuously refine and adjust the backlog based on changing priorities, regulatory updates, and stakeholder feedback.
• Stakeholder Collaboration and Communication:

• Act as the primary point of contact for stakeholders, including safety, regulatory affairs, quality assurance, and end-users of Aris Global, PSUR database, Safety database, and other pharmacovigilance platforms.
• Gather requirements, feedback, and insights from stakeholders to ensure that the platforms meet their needs and address regulatory concerns.
• Effectively communicate product decisions, roadmaps, and progress to stakeholders, fostering transparency and building trust.
• Release Planning and Execution:

• Collaborate with the development team to plan and execute product releases for Aris Global, PSUR database, Safety database, and other pharmacovigilance platforms, ensuring that they meet regulatory requirements, quality standards, and timelines.
• Participate in sprint planning, reviews, and retrospectives to ensure alignment and continuous improvement.
• Coordinate with cross-functional teams for testing, validation, and user acceptance, ensuring product quality and regulatory compliance.
• Risk Management and Compliance:

• Ensure that pharmacovigilance products and processes, including Aris Global, PSUR database, Safety database, and other platforms, comply with relevant regulatory requirements, industry standards, and best practices.
• Identify and mitigate potential risks associated with product development, implementation, and maintenance, collaborating with risk management and quality assurance teams as needed.
• Stay up-to-date with regulatory changes and industry trends, and adapt product strategies accordingly.
• Continuous Improvement:

• Continuously seek opportunities for process optimization, system enhancements, and user experience improvements for Aris Global, PSUR database, Safety database, and other pharmacovigilance platforms.
• Analyze product performance metrics, user feedback, and industry benchmarks to identify areas for improvement.
• Foster a culture of continuous learning and innovation within the team, encouraging collaboration and knowledge sharing.

About you

• Qualifications and Requirements : Bachelor\'s degree in a relevant field (e.g., life sciences, pharmacy, healthcare, or Technology with PV experience); advanced degree preferred.
• Experience with pharmacovigilance safety platforms such as Oracle ARGUS, ArisGlobal LSMV, Veeva VaultSafety, PSUR database, Safety database, and related systems.
• Possesses comprehensive knowledge of Quality Assurance and regulatory compliance, including 21 CFR Part 11 and FDA regulations, ensuring technology solutions meet industry standards.
• Strong problem-solving capabilities and a track record of successful project delivery.
• Proven experience in product management, preferably in the pharmaceutical or healthcare industry, with a strong understanding of pharmacovigilance processes and regulatory requirements.
• Excellent communication, stakeholder management, and problem-solving skills.
• Ability to translate complex regulatory requirements and business objectives into actionable product requirements.
• Strong analytical and decision-making capabilities, with a data-driven approach.
• Knowledge of Agile methodologies and experience working in cross-functional teams.
• Proficiency in relevant tools and technologies used in pharmacovigilance and product management (e.g., issue tracking systems, project management tools, requirements management tools).

Soft skills & Behaviours:

• Strong communication, negotiation, and interpersonal skills
• Demonstrated conflict resolution & problem-solving skills in a global environment.
• Strong appetite to learn and discover, entrepreneur mindset.
• Adaptable and open to change
• Team player, service-oriented
• Analytical and synthetic, able to formalize solutions, good writing skills.
• Strong oral and written communication skills
• With leadership attitude, autonomy and results driven.
• Role model our 4 values: teamwork, integrity, respect, courage

Education: Bachelor\xe2\x80\x99s degree in a relevant field; Master\xe2\x80\x99s degree preferred. Proven experience (8+ years) within the Lifesciences or consumer healthcare industry.Languages: Fluent spoken and written EnglishPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s be those people.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !

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