Working Opportunity as Medical Advisor in Clinical Safety Office at Sanofi
Sanofi -aventis, one of the world's leading pharmaceutical companies, is a team of 1,00,000 individuals driven by one common mission to improve people's health and quality of life. Present in more than 100 countries, we are vibrant, people centric, performance driven organization contributing to distinctive healthcare.
Post : Medical Advisor
Medical Advisor (MA) role:
MA is responsible for medical supervision and medical management of clinical trials .
• The Medical Advisor (MA) is the medical link between Medical Operations (and/or Units/Customers) and (potential) investigators or experts/KOL in countries.
• He/She should be the medical support in the territory for the studies he/she is allocated to.
• He/she should provide appropriate medical feedback to the clinical trial team especially to Clinical Study Director (CSD) and Feasibility Manager (FM).
• He/She ensures reliable commitment to perform (local / regional) operational feasibility or preassessment studies in liaison with the CPL and the study team.
• He/She develops strong network with local potential investigators.
• He/She authors the study outline / protocol / CRF / clinical study report of local studies, as necessary.
Clinical Safety Officer (CSO) Role:
The CSU Clinical Safety Officer (CSO) is accountable for the oversight of defined Pharmacovigilance tasks and safety documentation, and reporting of safety events (Individual Case Safety Reports -ICSRs), related to clinical studies and programs in humans (in the text: Clinical studies) being managed within his/her organization, according to Local Regulations and Corporate and Local Quality Documents (QDs).
• The Clinical Safety Officer is the primary local contact in the country/ies for Global Pharmacovigilance & Epidemiology (GPE) concerning Pharmacovigilance activities or matters on clinical studies.
• This role is key for supervision and management of all safety issues occurring in clinical studies performed in their country(ies). The CSO ensures appropriate training of local team, and appropriate review of safety at country or Cluster level.
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Clinical Safety
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