DDReg Pharma have urgent opening For Pharmacovigilance Quality Assurance (PVQA) Profile

Roles and Responsibilities

• Quality assurance support and expert advice to operational Pharmacovigilance (PV) Services activities within DDReg in order to ensure compliance with applicable regulatory requirements and DDReg procedures and quality standards.
• Support maintenance of the Pharmacovigilance System Master File (PSMF).
• Lead initiatives to maintain or improve quality performance and compliance of
  DDReg PV activities including case processing, medical safety, risk management, Health Authority reporting, PV IT systems and device vigilance; act as a quality champion.
• Lead and support initiatives focused on quality, process and compliance improvement through close collaboration with business partners, identify opportunities and develop strategies aimed at simplifying processes and improving quality while ensuring compliance with regulatory requirements.
• Ensure information gained during quality and compliance initiatives, as well as audit and assessment results, is evaluated to identify specific PV, regulatory, compliance and QA training needs for business partners.
• Lead the development, implementation and conduct of appropriate training.
• Lead and support in the development of corrective and preventative action plans (CAPA)
• Monitor status of corrective and preventative actions to ensure the issues are adequately addressed, completed and appropriately documented.
• Provide assistance in the remediation of PV -related deviations, ensure follow up and monitoring of associated corrective and preventive actions.
• Ensure quality and regulatory compliance issues are promptly communicated to appropriate management.
• Lead initiatives geared towards remediation of compliance concerns; determine effectiveness of remediation activities; provide ongoing project support and governance.
• Drive a culture of quality by close business partnering, to positively impact the business.
• Effective coordination, facilitation and follow-up of HA inspections Successful management of the PV-related actions of the PV/RA Quality Plan Timely escalation through proper channels of issues and findings that impact DDRegs PV.
• Effective collaboration on quality, compliance, remediation and improvement initiatives.
• Timely review and feedback on policies, guidelines and procedures.
• Timely and effective communication, consultation and support to business partners.

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