Global Periodic Reports Scientist

• Contributes to the design and development of PASR SOPs, QRGS, and applications for PASRs including the development and submission timeline, interface to SMEs within Global Patient Safety and non safety functions that support the PASRs, and QC of documents for completeness.
• Contributes to design and development of software to track PASR processes including the scheduling of PASRs and data specifications for the safety database outputs that support PASR generation.
• Assess the effectiveness of the PASR process for continuous improvement
• Responsible for fostering relationships with the external PASR vendor and all SMEs involved in the PASR process, the development and submission timeline, interface to Global Patient Safety, and QC of documents for completeness.
• Responsible for effective and accurate development and maintenance of Global regulatory requirements and standards for PASRs and serves as level 2 BPO for SOPs, QRGs and templates related to periodic reports.

• Translates PASR country requirements to ensure minimum number of PASRs are prepared to fulfill global needs, negotiating with Local Safety Officers and Regulatory Agencies to enable this.
• Responsible for the robustness of the periodic reporting process, successful alignment and tracking of PASR timelines for the scheduling, QC and key performance and key compliance metrics.
• Responsible for the periodic reports distribution process covering publishing, distribution, submission, and archiving in close collaboration with Business Partners, Contract Research Organizations, Global Regulatory Operations and Publishing teams,
• Ensure end-to-end process adherence by all SMEs involved in PASR process
• Responsible for accurate interpretation of regulatory requirements, internal working standards and guidelines to ensure the consistency of PASRs
• Represents the activities of Safety periodic reporting process planning in internal committees and with external parties such as regulatory agencies.
• Contributes to strategy for interactions and responses to health authority rapporteurs and oversight bodies such as PRAC.
• Ensure frequent interaction and collaboration with Global Patient Safety management e.g. TA Safety Group Heads and non-safety department leadership
• Responsible for ensuring *** adheres to and is aligned with Global Health Authority regulations and SOPS regarding all aspects of creating and submitting periodic reports. Monitor changes in regulations to ensure that *** remains compliant with evolving requirements of the relevant legislation
• Responsible to ensure cross-linking and consistency across periodic reports and across product teams to ensure standardization e.g. PBRER/PSUR and RMP
• Frequently trains and mentors PASR SMEs with respect to report production
• Lead or contribute to cross-functional initiatives aimed to improve pharmacovigilance capabilities to related periodic reports
• Apply and inform teams of new or revised regulatory requirements and guidelines relevant to periodic reporting
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Manages input from all PASR SMEs

• Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting
• Understanding impact of emerging regulatory requirements and their implications for ***
• Subject matter expertise and technical excellence
• Experience working on cross-functional teams
• Good knowledge of IT systems and IT standards
• Ability to effectively manage competing priorities and timelines
• Excellence in oral and written English
• Strong leadership skills, independence, networking and influencing skills and managerial experience to deal with potential conflict of stakeholders with the ability to bring a diverse group to a common decision
• Proven leadership skills in execution of goals and processes

• Ensures *** remains in compliance and becomes best in class with regard to periodic / aggregate report processes
• Responsible to ensure *** is active in regulations, guidelines and industry standards that affect the processes of the periodic report processes.
• Executes and maintains document standards
• Responsible for successful alignment and tracking of metrics, timelines and performance indicators for PASR objectives

Aequor Technologies