Manager, Pharmacovigilance Special Consulting Services

Manager of Pharmacovigilance Special Consulting Services

The Manager of Pharmacovigilance Special Consulting Services is responsible for the execution of operational tasks and all aspects of technical delivery and project management in the field of Pharmacovigilance. This is a remote based role that can be hired anywhere in the US.

Responsibilities :

• Case Management
• Individual Case Safety Report (ICSR) assessment of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; decision on expedited reporting; reporting of ICSRs to the competent authorities.
• Data entry quality control, including case assessment.
• Oversight of team Pharmacovigilance activities including ICSR reporting, reconciliations, follow up requirements, literature screening, signaling, inquiry and complaint management.
• Communication with regulatory authorities and clients regarding all pharmacovigilance-focused aspects.
• Participation, reviewing and approval of safety update reports PSURs (Periodic Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports) DSURs (Development Safety Update Reports), risk management plans and signal detection reports required and in support of risk-benefit profiling.
• Writing / Review of procedural documents such as Working Instructions, SOPs, Working Procedures, Templates etc. for PharmaLex PV projects.
• Program Management Support
• Overview of needed resources for their projects, and inform their Manager on an ad hoc basis.
• Review of Pharmacovigilance Intelligence Reports and perform gap analysis / impact assessment on own processes.
• Training of staff in selected areas of pharmacovigilance and client specific activities and requirements.
• Act as a mentor to colleagues new in their roles or new in various projects / tasks.
• Proactive in suggesting improvements to the services offered to our clients in the SCS service line.
• Client management
• The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.

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Experience :

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