Periodic Reporting Manager

Job title: Periodic Reporting Manager

• Location: Hyderabad

At Sanofi Consumer Healthcare, our Science Hub mission is to empower our consumers to take Health in their Hands! With your talent and ambition, we can do even more to build our Sciences activities and develop breakthrough innovations for consumers worldwide. Your job, as Periodic Reporting Manager within our Scientific Communications/Education

At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

Main responsibilities:

• Oversee and manage the global periodic reporting platform including personnel, activities from planning to distribution to appropriate stakeholders (Affiliates, Distributors, Business Partners).
• Provides leadership in the content for periodic reports (DSUR, PSUR) for CHC products.
• Provides guidance to staff regarding optimal practice regarding Periodic report activities which includes Planning, Authoring, Publishing, and distribution.
• Develop and maintain infrastructure to support the Periodic reports team, including hiring of staff, development of operating plans and budgets and allocation of resources to ensure budgets, schedules, and performance requirements are met.
• Responsibility for compliance with standard operating procedures (SOPs), global regulations/guidelines, corporate policies, and timeline
• Partner with the Vendor Management Head/delegate to manage and review selected vendor contracts, SOW, Change Order and invoices for appropriate documentation and approval prior to payment.
• Lead the Periodic Benefit-Risk Evaluation Report (PBRER) Quality Governance for the Company
• Drive collaboration and define contribution expectations with transversal contributors such as Regulatory, Medical, Clinical operations and commercial partners.
• Ensure the timely authoring and reporting of high quality and consistent periodic reports that meet internal and regulatory requirements as well as provide customer satisfaction.
• Ensure the regulatory compliance for all managed activities concerning global reporting of periodic reporting to Health Authorities
• Ensure appropriate outsourcing oversight is implemented for all outsourced periodic reporting activities.
• Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable.
• Act as product or process Subject Matter Expert (SME) during audits/inspections.
• Monitor performance trends and drive continue process improvements related to aggregate reports.
• Participate in or lead functional, departmental, and/or cross-functional projects and initiatives.

About you

Experience:

• Minimum of 5 years of Pharmacovigilance industry experienced required (at least 4 years in the Periodic reports area)
• Extensive relevant experience in pharmaceutical, consumer healthcare, FMCG and/or Personal care/Cosmetics industry is preferred.
• Soft skills: Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Proven leadership and team management skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment.
• Technical skills: Deep understanding of medical concepts and familiarity with safety activities in drug development and post-marketing and global safety health authority requirements.
• Education: Healthcare professional / Life Science advanced degree (eg PharmD, PhD, MasterD) required
• Languages: Fluent in English (verbal and written)

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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 ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s 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 ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!