PV Literature Surveillance Expert

Job title: PV Literature Surveillance Expert 

• 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 Literature Surveillance Expert (Open) 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:

• Formulate and maintain the search strategy/strategies in line with parameters provided by stakeholders to enable accurate and exhaustive identification and retrieval of scientific and medical literature articles from the literature database for ad hoc literature requests, regulatory requests and DSUR requests
• Send the citations retrieved to the requestor in the specified format
• Records are reviewed, and valid cases are entered into the database
• Identification and maintenance of local journals in scope for local literature search
• Performing Quality Check of the developed/updated search strategies and local journals.
• Perform periodic review of database thesauri updates and implementation of necessary changes to the search strategies in a timely manner.
• Interacting with internal or external contacts to resolve issues related to literature searches
• Assessing the literature references for validity (ICSR: Valid or Invalid and non-case)
• Requesting full articles
• Performing daily checks on the literature references for products provided on the EMA website and updating the respective tracker on SharePoint accordingly
• Performing checks for the reference of valid ICSRs availability in the PV Literature Monitoring System.
• Preparing bibliographic literature outputs for inclusion in NDA annual reports
• · Performs quality checks/ validation checks of literature articles by following a randomization process for selection of literature articles
   

About you

REQUIREMENTS

• Education: Master’s degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology).
• Experience: At least 3 years of experience in reviewing biomedical literature for adverse event reporting or an equivalent combination of education and experience.

SKILLS

• Strong knowledge of scientific terms, medical terminology, drugs, and therapeutic areas.
• Excellent writing skills for creating accurate and precise summaries.
• Ability to critically analyze large volumes of information.
• Familiarity with pharmacovigilance regulations and guidelines.
• Proficiency in using drug safety systems and databases.

KEY COMPETENCIES

• Attention to Detail: High level of accuracy in identifying and reporting safety information.
• Analytical Skills: Ability to assess and interpret complex scientific data.
• Communication Skills: Effective written and verbal communication skills.
• Time Management: Ability to manage multiple tasks and meet regulatory submission deadlines.

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!