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A Range of Possibilities

Project Specialist - Periodic Report Expert (PRE)

date posted 01/14/2022
contract type Full time
job id R2629184
location Hyderabad, India

Mission Statement

With >700 life-saving medicines including vaccines, Sanofi is serving millions of patients across the globe. Mutli-functional dynamic teams at Sanofi are constantly engaged to evaluate Benefit-risk profile of Sanofi’s marketed medicinal products to provide safe and effective medicines to patients. Your following expertise will help us in our endeavor to serve patients. We offer you most coveted organizational culture, facilities, and fair growth opportunities, which awarded us “Top Employer of 2021”.  

  • To lead/support preparation of periodic safety reports including but not limited to Addendum to clinical overview (ACO).
  • Conduct project Kick-off meeting and align line functions on the requirements as per the periodic report planning requirements.
  • Support co-ordination with different line functions and project management activities, to ensure timely receipt of information, its completeness and incorporation into ACO template as per the regulatory requirements
  • Author assigned sections of ACO and assemble different sections of ACO by liaising with different responsible line functions within Sanofi or its partners.
  • To complete data validation for different sections of ACO, quality and consistency check.
  • To proactively identify and resolve discrepancies to ensure consistency across document  
  • Perform peer-QC of entire ACO and support audit readiness checks
  • PRE works in close collaboration 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.
  • Ability to strive for excellence by supporting process improvement initiatives

Qualifications

  • Graduate/Post-graduate degree in Pharmacy (preferred) or life sciences
  • 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)
  • Excellent understanding of drug development process, pharmacovigilance, GVP, GCP, and medical terminologies  
  • Working knowledge of MS office tools (Word, Outlook, PowerPoint, and Excel), electronic document management (preferably Veeva-vault), and in MS Office 365 environment
  • Fluent in English (verbal and written)

Requirements of job

  • 2-4 years of experience in pharmacovigilance, clinical drug development or closely related areas of responsibility
  • Preferably, minimum 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)

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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