Require Associate Manager Drug Safety at Covance
Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you’ll have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential.
Post : Associate Manager Drug Safety
• General oversight for 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, oversight of the following types of tasks:
* Entry of safety data onto adverse event 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 cases receive appropriate medical review
* Prepare follow-up correspondence consulting with 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
* File maintenance
• General oversight for the management and processing of expeditable safety reports (ESRs). This includes, but is not limited to, oversight of the following types of tasks:
* review and update adverse event databases and tracking systems
* review of adverse events for completeness, accuracy and appropriateness for ESR
* review of patient narratives
* review the coding of adverse events
* review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
* file maintenance
• Maintain awareness of Covance’s safety database conventions and system functionality.
• Maintain awareness of other client safety database conventions and functionality.
• May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.
• Provide oversight and management of EudraVigilance activities for assigned projects.
• Contribute to the generation and review of Time and Cost Estimates for PV&DSS business.
• Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.
• Prepare and participate in audits, either by the client or a regulatory agency.
• Consistently contributes to solving technical and/or operational problems identified by program/project members.
• Consistently proposes and executes innovative solutions which influence program/project direction.
• Generation of monthly status, staff member performance and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
• Effectively draft/modify and deliver safety presentations:
* Client capabilities meetings, as appropriate
* “Department Overview” to internal clients
• Attend client meetings and liaise with clients where appropriate.
• Ensure compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
• Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
• Train new employees overall in pharamcovigilance and regulatory reporting.
• Maintain a comprehensive understanding of Covance PV&DSS’ SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
• Possess knowledge of all other CDS procedural documents that impact PV&DSS.
• Assist with the generation and review of SOPs, Work Instructions etc.
• Responsible for SOP implementation within assigned team.
• Assist in developing Operational metrics measuring PV&DSS’ overall performance.
• Assist with the recruitment of new staff to PV&DSS.
• Build and maintain good PV&DSS relationships across functional units.
• Demonstrate role specific Competencies on consistent basis.
• Demonstrate company Values on consistent basis.
• Financial authority as it relates to personnel and projects.
• Any other duties as assigned by management.
Professional designations/certifications/licenses required:
• Non-degree + 6-7 yrs safety experience* including 2 years of team leadership experience***
• Associate degree + 5-6 yrs safety experience* including 2 years of team leadership experience
• Associate degree RN + 5-6 yrs safety experience* including 2 years of team leadership experience
• BS/BA + 4-5 yrs relevant experience* including 1-2 years of team leadership experience
• MS/MA + 3-4 yrs relevant experience** (2-3 yrs safety experience) including 1-2 years of team leadership experience
• PhD / PharmD + 2-3 yrs relevant experience** (1-2 yrs safety experience) including 0-2 years of team leadership 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.
***Team leadership experience includes experience bearing overall responsibility for work products generated for customers by supporting team members operating in matrix environment, assigning and coordinating work executed by a team of supporting staff, organizing efforts of more than one individual to achieve common team objectives.
EudraVigilance Certification preferred
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