**Job title:** Global Pharmacovigilance Workflow & Oversight Manager + **Location:** Hyderabad **Main responsibilities:** + Responsible for maintaining case workload in CHAMPS (PV Database (DB)/LSMV) and ensuring the case timelines are within CHAMPS are met. + Ensure to a maintain healthy Work in Progress (WIP) case load for Opella. + Responsible for maintaining business architecture diagram (all modules in LifeSphere). + Responsible for maintaining configurations for LSR tool. + Maintain LSMV (CHAMPS) user manual with current SOPs/regulations and case processing conventions. + Responsible for trending analysis and alert the case management head for any abnormal increase/decrease in case volumes + Responsible for monitoring Capacity utilization of the resources. + This role will regularly engage with multiple vendors in different roles and capabilities related to Case Management (CM). + This role works cross functionally with internal Opella departments and external resources on ICSR and safety DB related matters. + This role will lead and define optimal business models to support business goals and ensure the operational model meets defined strategic key performance indicators (KPIs) crucial to business success for case processing vendor. + Ensure optimized process are deployed for ICSR receipt, assessment, follow up, data entry, medical evaluation, quality review, distribution, and submission in compliance with SOPs/regulations. + Provide ongoing oversight to ensure a consistent and compliant approach to understanding Opella PV needs and focus on continuous improvement to identify efficiencies. + Maintains operation reports from LifeSphere Reporting & Analytics (LSRA)/ LifeSphere Multivigilance (LSMV) and ensures the implementation of effective CAPA plans for identified deviations in CM activities. + Support QC lead and work closely with SMEs and Quality Assurance (QA) to improve and exceed quality standards, to identify process improvements and to ensure CM resources have necessary training and skills. + Responsible to ensure training slides and attendance sheets for all PV trainings. + Assists in CHC case migrations for divestments/ acquisitions and support monitoring quality & timeliness and complete documentation audit trail of DM. + Participates in business continuity arrangements and assists with the authoring and implementation of PV Operations business continuity plan (BCP) processes. + Collaborates with CHC PV ops leads, CSH and Regulatory Affairs to monitor the processing, submission and tracking of expedited safety reports to appropriate domestic and international regulatory authorities. + Participate in the development and continuous improvement of processes, workflow, and supporting documents. + Other PV tasks as required. **_About you_** **Experience** : + _Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc._ + _Experience in case processing activities._ + _Experience in team management_ + _Experience in overseeing vendors responsible for case processing._ + _Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation_ + _Good knowledge of MS Office_ + **_6-8_** _years of pharmaceutical industry experience with a focus on pharmacovigilance with min 2 years in managing team_ + _Strong experience in ICSR quality review and submissions_ + _Incumbent should have experience in Process Improvement practices_ **Soft skills** : + _Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions._ + _Time Management: Ability to manage multiple projects and deadlines effectively, ensuring that safety reports and data analysis are delivered on time._ + _Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities._ + _Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams._ + _Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way_ + _Excellent team-work and interpersonal skills_ + _Ability to work in cross-functional teams_ + _Excellent oral and written communication skills_ + _Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way_ **Technical skills** : + _Understanding of Adverse Event Reporting: Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports_ + _Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities._ + _Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards._ + _Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards._ + _Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data._ + _Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings)._ + _Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders._ **Education** : _Bachelor’s degree in pharmacy / Life Sciences / equivalent Academic qualification is desirable with 6-8 years of experience and min. 6 years in Global PV case processing activities_ **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, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. 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