R&D- CDAIP- Sr. Medical Coding Specialist - CD
Sanofi Group
**About us**
At Sanofi, we chase the miracles of science to improve people’s lives. All our decisions are taken with our most important stakeholder in mind – the patients.
Having a rich history of innovation that dates back over 100 years, Sanofi more than ever stays true to its commitment to transform the practice of medicine by providing potentially life-changing treatments and the protection of life-saving vaccines to millions of people. This history includes the first treatments for many rare diseases and the establishment of standards of care in diabetes and cardiovascular disease. Sanofi’s commitment to public health has helped protect hundreds of millions of people from influenza every year for decades and pushed polio to the brink of eradication, while its scientific vision has led to breakthrough innovations in the treatment of inflammatory diseases.
~ 43.07Bn€ Net Sales FY23
~90 countries
~ 91K employees
~ 59 manufacturing sites
~ 20 R&D sites
**Who we are?**
As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development t as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.
**Why start your career path in Sanofi?**
The coding specialist ensures coding of medical events and medications using regulated dictionaries and in compliance with international rules. He/she is fully aware of the dictionaries structure and updates and their related impacts on terms classification. He/she validates the coding, with input from Clinical Research Director (CRD), taking into consideration medical aspects such as the compound mechanism of action, the study population or any specificity as defined in the study protocol. He/she can provide input on CRF design. He/she, in collaboration with case medical safety evaluator (CMSE), ensures that SAE are reported and coded in a consistent way within both clinical and GPV database. He/she can detect and alert the CRD for unexpected medical events. The coding specialist can be dedicated to one therapeutic area (Oncology, Diabetes, …).
Main Responsibilities:
-Coding referent for study (ies) he/she is allocated to, primary contact for coding concerns.
-Accountable for the coding of events and drugs (in compliance with ICH guidelines for events), ensure ongoing coding of studies including query generation for ambiguous medical terms.
-Ensure coding accuracy and consistency review, for self or pairs.
-Medical validation of adverse event reporting with CRD.
-Ensure coding reconciliation of SAE with GPV.
-Help in appropriate documentation and investigations of safety cases in collaboration with GPV, identify reporting issues and provide solutions.
-Provide input on protocol particularly for exclusion criteria related to coded data.
-Provide input and help in CRF design (pre-printed events, medication categories, etc…).
-Review study documentation (CMP,DMP, …) for coding related elements.
-Propose coding related edit checks to Data Manager.
-Attendance to study team meetings and explanation or training to study team members when appropriate.
Required Knowledge And Skills:
- Ability to communicate and work within a global team
- Ability to understand and process several levels of information for multiple projects
- Knowledge in ICH, GCP
- Good command of the English language
- Working knowledge of various coding systems and related third party tools, familiar with auto-encoding algorithms
Required Education/Experience:
- Physician, Pharmacist, Nurse or paramedical professional with minimally a Bachelor Sciences.
- Previous experience in coding and coding dictionaries in one or several Therapeutic Area, preferably MedDRA, WHODD 5 years - Previous experience in Clinical Research and/or Drug Development 5 years **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 (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) !
**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) !
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
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. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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