Job title: Project Specialist - Periodic Report Expert (PRE)

• Grade: NA
  

• Hiring Manager: Head Scientific Communications/ Project Manager
  

• Location: Hyderabad/ Mumbai
  

• % of travel expected: Travel required as per business need
  

• Job type: Permanent and Full time
  

About the job

Our Team:

Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

Main responsibilities:

To evaluate the Benefit-Risk profile of Sanofi'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'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 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 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 Global Hub 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'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 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 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)
  

Pursue progress, discover extraordinary

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, disability, or gender identity.

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