PV Case Management Manager

Job title: PV Case Management 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 PV Case Management Manager  within our Scientific Communications/Education                           
About Sanofi :

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:

• The position is the process owner for case management globally in the Company, accountable for group wide alignment of ICSR management standards and processes including receipt, assessment, follow up, data entry, medical evaluation, quality review, distribution and submission within strict internal and regulatory timeframes to deliver quality case data to downstream analysis processes.
• Ensure timely compliance to Health Authorities globally for expedited ICSR reporting
• Manage the overall processing of ICSRs in the PV database. Thorough, medically-meaningful high quality ICSRs processed within required internal and regulatory timeframes.
• Oversee resource allocation, recruitment and training of personnel. Adequate numbers of personnel with background and training appropriate to incumbent and promotional positions.
• Drive process improvements that support improved compliance, quality and efficiency though adoption of industry-wide procedures.
• Oversee participation of case medical evaluators in safety analysis team for input of contextualized case data into the surveillance process and feedback on data requirements. Early Identification and management of potentially-important product safety issues. 
• This includes oversight of local country, regional, corporate and vendor activities for ICSR processing
• Provide platform support for signal activities and GSO activities
   

About you
Experience:

• Minimum of 10 years Pharmacovigilance experience including the preparation of Safety Analyses for submission to regulatory authorities.
• Soft skills: Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment.
• Technical skills: Knowledge of International Regulatory requirements, thorough knowledge and experience in all aspects of Pharmacovigilance impacted by ICSRs, working knowledge of clinical medical practice and pathophysiology, working knowledge of computer systems and data processing.
• Education: MD or Pharm D with at least 5 years patient-care experience.
• 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!