Pharmacovigilance And Quality Assurance Specialist

Scope of Responsibilities:
Pharmacovigilance (PV)
• Implements and maintains the local vigilance system and its quality system, including management of local Standard Operating Procedures (SOPs) and related indicators, audits and inspection readiness, and record management of relevant documentation.
• Manages safety information received from any sources including their receipt, follow-up, reconciliation, documentation, and submission to local authorities in accordance with local and global SOPs, third-party agreements and regulatory requirements.
• Conducts screening of local literature and ensures adequate monitoring of digital media and social networks to identify safety reports involving Galderma products.
• Contributes to the conduct and oversight of post-marketing studies sponsored and managed by Galderma Vietnam, i.e., non-interventional studies, interventional studies, post-authorization safety studies, investigator-initiated trials, patient support programs, drug utilization studies, market research, etc.
• Implements and maintains Safety Data Exchange Agreements (SDEAs) with local Vigilance Agreement Partners (VAPs).
• Establishes and delivers vigilance training to affiliate and local VAP employees, and maintenance of training records.
• Organizes the regulatory intelligence and business continuity of vigilance activities.
• Notifies the JPAC PV Head and Global PV Compliance of any announcement of inspection by the local authorities or audit by a local VAP; leads local vigilance inspection and audits activities; and is responsible for the development, implementation, follow-up, and resolution of Corrective and Preventive Action (CAPA) plans.
Quality Assurance (QA)
• Responsible for ensuring Good Distribution Practice (GDP) for products imported and wholesaled by Galderma Vietnam (e.g., proper distribution and traceability of medicines).
• Appointed as Quality Representative to chair Quality and Vigilance management review meetings.
• Perform Quality and compliance specific tasks including but not limited to processing product complaints (i.e., damages or counterfeits), management reviews, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination.
• Ensure local repackaging of products is performed in accordance with specifications and required licenses.
• Ensure affiliate 3rd parties are qualified, maintained in approved status and technical quality agreement established.
• Support principal release of products received inbound, if required.
• Authorization of product from quarantine to approve status, disposition for trade returns and damaged products, if required contractually with third parties.
• Process owner of quality systems such as, but not limited to, internal audits/self-inspection, change control, management reviews, deviation management and CAPA.
• Maintenance, analysis and reporting of Quality KPIs.
• Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs.
• Implementing and maintaining the QMS to ensure that required processes are established.