Require Centralized Study Associate at Covance @ Apply Now

Post : Centralized Study Associate I

Job Description
1. Follow applicable departmental Standard Operating Procedures and Work Instructions.
2. Complete required trainings according to required timelines.
3. Complete day-to-day tasks ensuring quality and productivity.
4. Maintain project and technical documentation in an appropriate manner.
5. Perform checks to ensure quality of work completed.
6. Ensure timely escalation as needed.
7. Other duties as assigned by study management.
8. Manage clinical systems
9. Manage study documents
10. Maintain study databases (Clinical Trial Management System CTMS, Interactive Web Response Systems IWRS, Electronic Data Capture. EDC etc.)

Candidate Profile
• Demonstrated ability to organize and communicate effectively.
• Demonstrated ability to pay attention detail.
• Ability to work well with others.
• Ability to deliver consistent high quality of work.
• Ability to use computer and departmental tools.
• Support a culture that fosters teamwork and innovation
• Willing to work in shift operations (either morning shift or evening shift)

Education: If you are Graduate or Post-Graduate in Pharmacy / Life Sciences (2017 / 2018 batch pass out) with a minimum of 60% and above, and having 0-6 months of work experience. Certification course in Clinical Research will be an added advantage. If this excites you, then you can make the most of your extraordinary potential at Covance. Covance operates in two shifts (Morning and Evening shifts) and candidates will be required to work in one of the shifts.
Experience: 0-6 months of work experience. Certification course in Clinical Research will be an added advantage.

Additional Information
Experience : 0-6 months
Qualification : B.Sc, M.Sc, M.Pharm, B.Pharm
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Monitoring
End Date : 31st January, 2019

Require Auditor in Quality assurance, Control at Covance @ Apply Now

Post : Auditor II QA&C
Job Description
• As assigned, schedules, conducts and reports routine QA audits in accordance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
• Provides suitable recommendations for audit observations; ensures auditees provide appropriate CAPAs and follows them up through closure
• Participates in complex, directed and/or global QA audits
• Supports process improvement activities / SOP updates
• Supports client audits and regulatory inspections
• Participates in special projects
• Represents Audit QA on project teams and other internal forums
• Able to support client audits and regulatory inspections

Candidate Profile
• University/college degree BA/BS (life sciences preferred) or equivalent experience
• Knowledge, understanding and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs
• Knowledge of the drug development process from the perspective of a contract research organization

Additional Information
Experience : 5+ year
Qualification : University/college degree BA/BS
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : QA&C
End Date : 31st January, 2019

Require Project Manager Drug Safety at Covance @ Last date 20 december 2018

Post : Project Manager Drug Safety

Job Description
The Drug Safety Project Manager manages specific Pharmacovigilence and Drug Safety Services operations associated with assigned products, including the entire adverse events process from trial to post marketing. You will monitor and manage the workflow for assigned projects with responsibility for making decisions regarding adverse event reporting within specific guidelines. Additional responsibilities include but are not limited to:
• Work closely with the clinical operations and project management teams to ensure all PV & DSS activities are performed according to the regulatory and contractual requirements of the study.
• Provide oversight of the receipt and processing of all adverse event reports including entry of safety data, writing patient narratives, and coding adverse events in MedDRA.
• Identify clinically significant information missing from initial reports and collect missing data
• Ensure the cases receive appropriate medical review
• Prepare follow-up correspondence consulting with the medical staff accordingly

Candidate Profile
• University degree in Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry preferred
• A minimum of 7 years experience in Drug Safety*
• Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
• Working knowledge of relevant worldwide pharmacovigilance regulations and guidelines
• Working knowledge of GCP/ICH guidelines related to clinical safety documentation
• Experience with aggregate reporting
• Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance

Additional Information
Experience : 7 years
Qualification : B.Pharm, B.Sc
Location : Mumbai
Industry Type : Pharma
Functional Area : Drug Safety
End Date : 20th December, 2018