Work as Drug Safety Allocator in Covance
Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Post: Drug Safety Allocator
• Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
- entry of safety data onto adverse event database(s) and tracking systems
- review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- write patient narratives
- code adverse events accurately using MedDRA
- determine expectedness/listedness against appropriate label
- identifies clinically significant information missing from initial reports and ensures its collection
- ensure case receives appropriate medical review
- prepare follow-up correspondence consulting the medical staff accordingly.
- ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
- reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
- provide independent QC of AE reports for other members of the group
• May execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.
• Maintain a strong understanding of Covance’s safety database conventions or client-specific database conventions, as appropriate.
• Participate in signal detection, trend and pattern recognition activities, as appropriate.
• Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings, and aggregate reports.
• Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as a lead contact for projects including global projects ensuring communication and process harmonization.
• Work with Data Management or client on reconciliation of safety databases, if appropriate.
• Monitor workflow for assigned studies/programs to ensure all deadlines are met.
• Non-degree + 5-6 yrs safety experience*
• Associate degree + 4-5 yrs safety experience*
• Associate degree RN + 4-5 yrs safety experience*
• BS/BA + 3-4 yrs safety experience*
• MS/MA + 2-3 yrs relevant experience** (1-2 yrs safety experience)
• PharmD + 1-2 yrs relevant experience** (1 yr safety experience)
For PharmD, a one year residency of fellowship can be considered relevant experience.
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
• Good verbal, written and presentation skills.
• Good communication.
• Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
• High degree of accuracy with attention to detail.
• Functions as a team player.
• Ability to present and share useful business information across departments and functions.
• Ability to anticipate and identify problems and take appropriate action to correct.
• Knowledge of medical and drug terminology
• Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
• Knowledge of ICH Guidelines
• Knowledge of Medical Device reporting desirable
• Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
• Good knowledge and understanding of industry and R&D processes and objectives.
• Ability to work independently with minimal supervision
• Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
Experience: 1-6 years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Type: Full Time
Employment Type: Permanent
Requisition ID: 51960BR
End Date: 15th April, 2015
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