Assoc Director, Medical Reviewer Job
POSITION: Associate Director, Medical Reviewer, Global Drug Safety & Risk Management (EMEA/APAC)
SUPERVISOR: Director, Case Management & Trial Safety Operations
DEPARTMENT: GDSRM EMEA/APAC
PREREQUISITES: MD or international equivalent
PURPOSE
To provide medical advice and input to the activities of AE Case Management
To contribute to global pharmacovigilance & trials activities through ensuring appropriate operational output and support
To act as a significant point of contact between Case Management, Trials Safety and PV/EPI
KEY RESPONSIBILITIES
Ensuring medical accuracy of all aspects of the Case Management group's output
Developing procedures in support of the Global Safety department having a significant medical context
Ensuring internal escalation of cases as appropriate
Responsibilities will include, but are not limited to, the following:
Execute the medical review of AE reports (narrative, coding, labeling, causality, company comment) and manage corrections with Assessment providing feedback to DSS and concerned Mgrs as applicable
Review and update generated follow-up letters as appropriate
Review weekly line listing of non-serious cases and manage changes as appropriate
Distribute and discuss cases with other company MDs as needed
Communicate with Lead Safety Physician for cases of special interest or SUSAR reports from clinical trials and generate discussions with relevant parties (PV/Epi, Trials Safety Staff)
Present cases of interest to Global Drug safety peers during safety meetings.
Contribute to the resolution of issues from case of increased complexity through medical expertise and team interactions
Manage review of cases and transmission for submission according to internal timelines
Support SAEs reconciliation in relation to coding mismatches
Contribute to the creation & updating of conventions/templates
Contribute to the communication of quality performance findings
Provide input to PSURs as required
Develop targeted questionnaires in collaboration with Lead Safety Physician
Contribute to product launch plan development & implementation
Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
Participate in relevant meetings within the drug safety department ( eg Product meeting, CM Meeting, MR meeting)
Outputs
Coordination measures within the Drug safety Dept
Medically accurate SAE/AE reports
Follow up documentation
Decision Making Authority
Medical content of SAE/AE reports
Coding conventions and consistency
Medical content of SAE/AE case follow up needs
Qualifications
Skills/Knowledge Required:
Experience
Extensive relevant experience, including training
Drug safety experience
Clinical experience preferred
Knowledge
Medical aspects of drug safety
Pre- and post-marketing safety practice
Regulatory requirements across drug safety
Clinical development process and operations
Use of safety data in aggregate analysis
Competencies
Flexibility
Attention to details
Negotiation
Initiative
Compliance and Risk Management
Change management
Foster Teamwork
Demonstrate transparency and open effective communication (oral/written)
Effective interactions and diplomacy
Time Management and Prioritization
Organization skills
Dealing with Ambiguity
Req ID:
Primary Location: United Kingdom-England-Hillingdon
Job: Drug Safety
Organization: Celgene Europe LTD
Schedule: Regular
Shift: Standard
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 10 % of the Time
Job Posting: 2014-09-:00:00.0
SUPERVISOR: Director, Case Management & Trial Safety Operations
DEPARTMENT: GDSRM EMEA/APAC
PREREQUISITES: MD or international equivalent
PURPOSE
To provide medical advice and input to the activities of AE Case Management
To contribute to global pharmacovigilance & trials activities through ensuring appropriate operational output and support
To act as a significant point of contact between Case Management, Trials Safety and PV/EPI
KEY RESPONSIBILITIES
Ensuring medical accuracy of all aspects of the Case Management group's output
Developing procedures in support of the Global Safety department having a significant medical context
Ensuring internal escalation of cases as appropriate
Responsibilities will include, but are not limited to, the following:
Execute the medical review of AE reports (narrative, coding, labeling, causality, company comment) and manage corrections with Assessment providing feedback to DSS and concerned Mgrs as applicable
Review and update generated follow-up letters as appropriate
Review weekly line listing of non-serious cases and manage changes as appropriate
Distribute and discuss cases with other company MDs as needed
Communicate with Lead Safety Physician for cases of special interest or SUSAR reports from clinical trials and generate discussions with relevant parties (PV/Epi, Trials Safety Staff)
Present cases of interest to Global Drug safety peers during safety meetings.
Contribute to the resolution of issues from case of increased complexity through medical expertise and team interactions
Manage review of cases and transmission for submission according to internal timelines
Support SAEs reconciliation in relation to coding mismatches
Contribute to the creation & updating of conventions/templates
Contribute to the communication of quality performance findings
Provide input to PSURs as required
Develop targeted questionnaires in collaboration with Lead Safety Physician
Contribute to product launch plan development & implementation
Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
Participate in relevant meetings within the drug safety department ( eg Product meeting, CM Meeting, MR meeting)
Outputs
Coordination measures within the Drug safety Dept
Medically accurate SAE/AE reports
Follow up documentation
Decision Making Authority
Medical content of SAE/AE reports
Coding conventions and consistency
Medical content of SAE/AE case follow up needs
Qualifications
Skills/Knowledge Required:
Experience
Extensive relevant experience, including training
Drug safety experience
Clinical experience preferred
Knowledge
Medical aspects of drug safety
Pre- and post-marketing safety practice
Regulatory requirements across drug safety
Clinical development process and operations
Use of safety data in aggregate analysis
Competencies
Flexibility
Attention to details
Negotiation
Initiative
Compliance and Risk Management
Change management
Foster Teamwork
Demonstrate transparency and open effective communication (oral/written)
Effective interactions and diplomacy
Time Management and Prioritization
Organization skills
Dealing with Ambiguity
Req ID:
Primary Location: United Kingdom-England-Hillingdon
Job: Drug Safety
Organization: Celgene Europe LTD
Schedule: Regular
Shift: Standard
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 10 % of the Time
Job Posting: 2014-09-:00:00.0