...monitoring experience
• Knowledge of international standards (GCP/ICH, Food & Drug Administration (FDA), European Medicines Agency (EMA)
• Understanding the purpose of the CRA (Patient Safety; Data Integrity; Principal Investigator (PI) Oversight; GCP/ICH & Protocol Compliance...
...understand English.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take...
...organizational skills.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take...
...with high quality
~ Experience handling industry standard public databases/ data sources like Clinicaltrials.gov, Pubmed, FDA website, EMA website; and/or paid databases like Citeline, Evaluate Pharma, PharmaTell, etc.
~ Excellent written and verbal communication skills...
..., and persuade.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the...
...MustHave:
Experience in CSV (Computer System Validation)
Understanding of the regulatory guidelines for IT systems primarily FDA EMA MHRA and PMDA
JD:
1. Exposure to pharmacovigilance domain and drug safety applications Argus or ArisG/J
strong preference
2....
...simplifications/ automations
Take responsibility of documenting and getting the testing done for allocated policies/ controls
Assist in EMA and Global review programs
Active role in the overall annual Quality and Compliance Evaluation program / SoQM evaluation process at...
...Oracle ERP system
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take...
...internal and external stakeholders.
# Deep understanding of pharmacovigilance processes and regulations including knowledge of FDA and EMA requirements.
# Experience working in a global environment with the ability to collaborate effectively with colleagues and customers...
...LeaderERP System Expert
Experience 10 to 15 years
Location Panchkula/Gurgaon
Must have
Experience in ERP modules.(HR/PYFICO ESSMSS EMA or PM MM AM DMS)
Experience in ERP implementation.
Experience in Government Projects.
Projects completed worth Rs.INR 100 Cr. (...