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Manager Physician Vaccines Safety Evaluation and Risk Management
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Manager Physician Vaccines Safety Evaluation and Risk Management : GlaxoSmithKline
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| Job Number |
72780 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
King of Prussia
Pennsylvania
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
1/10/2012 |
| Industry |
Pharmaceutical |
| Job Type |
Other |
| Relocation |
Not Required |
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| Description |
Basic Qualification
• Medical degree
•Pharmaceutical, clinical practice, or academic experience
•Experience using advanced evaluation skills and analytical thinking for scientific literature review, data gathering, data synthesis, analysis and interpretation
• Experience with medical and scientific writing
•Experience with a broad range of computer applications
• Knowledge of other relevant disciplines (e.g., statistics, pharmacoepidemiology and associated methodologies) pertinent to assessing drug utilization and safety at the population level
•Knowledge of medical and drug terminology and experience exercising medical judgment
• Experience applying an understanding of the drug development process and the drug approval process in major countries
Details
Responsible for the continued safety assessment, evaluation and risk management of major GSK vaccines or vaccine groups in clinical development or the post-marketing setting.
Ensures that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates, and drive proactive implementation of risk management initiatives
Provides significant and proactive clinical safety input on cross-functional teams (including Safety Review Teams) and ensures that appropriate safety objectives and risk minimisation strategies are included in clinical development programs
Provides medical input and analyses for regulatory documents, including Periodic Safety Update Reports (PSURs) and Developmental Safety Update Reports (DSURs)
Safety Governance and Risk Management activities
• Conducts, or leads with guidance, pharmacovigilance and risk management planning for designated vaccines, including preparation of global Benefit-Risk Management Plans, in partnership with the product scientist
• Contributes to regulatory benefit-risk assessments and contributes to the regional Risk Management Plans for designated vaccines
• In partnership with the product scientist, provides the clinical safety input into Clinical Development planning activities
• Represents BCSP on cross-functional ad-hoc teams set up to address urgent and important safety issues
• Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
• Facilitates establishment of Safety Review Teams as necessary, provides data for review and actively contributes to interpretation and discussion. May chair a Safety Review Team. Ensures that risk-reduction strategies are implemented appropriately in relevant documents such as clinical study protocols and/or product labelling
• Provides medical input for risk evaluation and risk management
Signal Detection, Evaluation and Labelling
• Runs routine signal detection process (including On-Line Signal Management Tool, literature review and tools for individual case awareness) for all vaccines in area or responsibility. Provides medical input to signal detection and subsequent evaluation for designated products in partnership with in product scientist and more senior physician
• Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals. Takes the lead role in data evaluation and discusses the results with the TA Director/product scientist and other key stakeholders (e.g. Clinical Development groups)
• Presents on labelling recommendations for complex issues to GSK Global Labelling Committee or Global Safety Board
• Produces regulatory supporting documentation for labelling updates
• Produces accurate and fit-for-purpose signal evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data. Provides strategic input into regulatory requests for local label deviations from the company core data sheet, in partnership with the product scientist
• Provides medical sign-off for regulatory documentation and represents BCSP as the medical member of labelling discussions with guidance from TA Head
• Routinely monitors safety issues potentially related to a product defect and/or manufacturing issue; communicates with the product scientist/ TA Director and/or Manufacturing; documents outcome
• In consultation with the product scientist, Clinical Development representatives and Global labeling specialist, prepares and updates the Developmental Core Safety Information (DCSI) and Global Data Sheet (GDS) for assigned development vaccines; co-ordinates meetings and tracks timelines to ensure completion
Regulatory Reports and Submissions
• Contributes to periodic regulatory documents (PSURs, Annual Reports) according to the agreed process and timelines. Co-ordinates the compilation of large PSURs requiring a team approach and provides high-level summaries of major issues.
• Provides medical input, review and sign-off of periodic reports (e.g. PSURs) and renewal documentation submitted to regulatory agencies, under supervision of TA Head
• Authors the SERM safety contribution to global regulatory submissions for new products, formulations or indications, and label updates, in partnership with the product scientist and liaison with other functional experts (e.g. Clinical Development, Regulatory Affairs) |
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| Requirements |
Preferred Qualification
• Prior pharmacovigilance experience
• US or Canadian training and Board certification; medical subspeciality training
• In depth knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
• In depth understanding and experience in evaluation of safety signals and proactive risk management strategies, including management of labelling changes, physician and patient education and monitoring of safety issues
• Sound knowledge of vaccines
• Knowledge of GSK systems and organization
• Experience summarizing complex safety issues |
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