Periodic Report Planning Expert

At Sanofi Consumer Healthcare (CHC), 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 “Health in Your Hands”. 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 fulfil 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 “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”. 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 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 Team: The Global Regulatory Strategy & Science Partner Markets Team is a diverse and inclusive team striving to Build a culture of excellence by: Driving operational effectiveness for regulatory processes Enabling strategic decision making on global regulatory strategy portfolio Bridging regulatory portfolio activities with brand needs Monitoring regulatory performance and budget Ensuring operational excellence and ensuring continuous improvement in Partner Markets (G2) for Science Creating value through a best in class CoE structure, processes and talented resources The CHC Science Center of Excellence (CoE) is an internal resource organization based in India and is set-up to centralize processes and activities to run and support Science Customer functions. The CoE strives to be a partner for strategic and tactical deliveries for CHC Science globally to sustain world-class performance and value.

Main responsibilities:

To evaluate the Benefit-Risk profile of Sanofi CHC’s marketed medicinal products to provide safe and effective medicines to patients. To support the preparation of periodic safety reports including, but not limited to, the Addendum to clinical overview (ACO).

Essential Job duties and responsibilities:1)Conduct project Kick-off meetings and align line functions on the requirements as per the periodic report planning requirements. 2) Support coordination with different line functions and project management activities, to ensure timely receipt of information, its completeness, and incorporation into the ACO template as per the regulatory requirements. 3) Strong organizational and project management skills. 4) Organize and prioritize workload/multiple requests to comply with agreed timelines and ensure that Sanofi CHC’s business needs are met. 5) Author the assigned sections of ACO and assemble the rest of the sections of ACO by liaising with different responsible line functions within Sanofi CHC or its partners. 6) To complete data validation for different sections of ACO, quality, and consistency check.

To proactively identify and resolve discrepancies to ensure consistency across the document. 7) Perform peer-QC of the entire ACO and support audit readiness checks. 8) Ability to strive for excellence by supporting process improvement initiatives. 9) Collaborates effectively with different Sanofi CHC line functions including (but not limited to) Medical, Regulatory, Pre-clinical, Pharmacovigilance, Statistics, Clinical Leaders, and Project Leaders, external partners responsible for contribution and operational delivery of ACO.

• People: 1) Maintain effective relationships with stakeholders from several line functions with an end objective to ensure comprehensive and consistent aggregate analysis is performed to establish the benefit/risk profile of the product that meets Health Authority requirements. 2) Actively lead assigned projects and develop Sanofi CHC Science CoE operations activities. 3) Ensure new technological updates are embraced and leveraged. 4) Follow up with all contributors to ensure the timely completion of reports within specified regulatory timelines. 5) Provide technical support to authors/contributors with regard to electronic document management and ACO or GVP guidelines. 6) Coordinate work that is subcontracted to vendors/CROs, providing technical support to vendors, seeking/identifying solutions, facilitating interaction and exchange of information, and overseeing/managing vendor activities.
• Performance: 1) Ensure periodic safety reports (ACO) are prepared, archived, and delivered as per agreed timelines in adherence with Sanofi CHC’s quality standards. 2) Perform format, consistency check, and pre-submission-readiness of assigned periodic safety reports (ACO) for publishing purposes. 3) Act as an independent quality reviewer for periodic safety reports (ACO) assigned to peers/vendors to ensure the information presented is complete, consistent, and compliant with the regulatory and Sanofi CHC standards.
• Process: 1) Support the delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards for periodic safety reports (ACO) prepared for the CMO group, including appropriate archival of all relevant documents in the document management systems to meet Health Authority- and Company-specific audit requirements. 2) Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the CMO group. 3) Secure adherence to compliance procedures and internal/operational risk controls in accordance with applicable regulatory/company standards. 4) Perform transversal activities, including mentoring the newly joined team member, identifying the need for PSR training, communicating the day-to-day potential challenges in deliverables, performing specific types of training, and participating in the development of new tools/initiatives. 5) Support Health Authority inspections/audits and development of corrective and preventive actions (CAPA) to address findings
• Stakeholders: 1) Work closely with CMO and vendor teams in regions/areas to ensure timely deliverables. 2) Liaise with the CMO team to prepare relevant & customized deliverables.

About you

• Experience: 2-4 years of experience in pharmacovigilance, clinical drug development, or closely related areas of responsibility;             Preferably, a minimum of 2 years of relevant experience in authoring and co-ordination of periodic safety reports; Direct pharmaceutical industry experience should be within comparable sectors or roles (periodic safety reporting/aggregate reporting/project specialist role)
• Soft skills: Stakeholder management, Project management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions,propose technical solutions based on previous experience and expertise gained within the PRE role, ability to understand and identify priorities for the purpose of negotiating timelines
• Technical skills: As applicable (including but not limited to Working knowledge of MS office tools (Word, Outlook, PowerPoint, and Excel), electronic document management (preferably Veeva-vault), and in MS Office 365 environment, a strong and thorough knowledge of MS WORD functionality and advanced skills in using Adobe Acrobat, Understanding the valid criteria for challenging various demands of users/customers, Knowledge of periodic safety report (ACO) document lifecycle and electronic Document Management System,   Understand regulatory (Health Authority) requirements related to document template and requirements of each section, Regulatory reports pre-submission readiness and submission, Knowledge of ACO and periodic report authoring and co-ordination, GVP regulation and product renewal (ACO) regulation, and template requirements (hands-on experience on Sanofi CHC procedures will be preferred), and excellent understanding of the drug development process, pharmacovigilance, GVP, GCP, and medical terminologies 
• Education: Graduate/Post-graduate degree in Pharmacy (preferred) or life sciences
• Languages: Fluent in English (verbal and written)