PV Specialist-PV QA Audit

Roles & Responsibilities

• Support the Global Head Pharmacovigilance Quality Assurance in defining the strategy for and਎stablishਊ robust, integrated PV Quality Management System.

• Drive the development, implementationਊnd oversight of all quality aspects of the Pharmacovigilance Quality Management System (PV QMS).

• To work closely with the Global Head of PV QA, Global Head of PV, and Regional/Functional Heads to help define PV QMS strategies and ensure the fulfilment of regulatory requirements.

• Actਊs ak-up/designee to Global Head PV QA,ਊs required.

• Support in thereation, revisionਊnd withdrawal of PV-related procedural਍ocuments.

• Ensure PV processes haveਊppropriate਍ocumentationਊnd identifyਊny process gaps. Maintain document review and life-cycle.

• Reviewਊnd provide input to PV਍ocumentsਊs needed to਎nsure PV processesਊrequately਍ocumented.

• Provide QA support in the roll-out of IT tools in the Pharmacovigilanceਏunction.

• Support in achieving a robust, inspection-ready quality management system for PV which meets internal quality standards and global regulatory requirements for PV quality.

• Provide support for theonduct and management of regulatoryਊuthority inspections.

• Support preparation efforts including training of personnel on inspection behavior and how to answer inspector questions,ਊssist in the generation of story boards to cover keyਊreasਊnd to provide SME lists for interview. Manage the logisticsਏor the inspectiononduct, including availability of rooms, scribe, and technology as required.

• Support the Global Head Pharmacovigilance Quality Assurance in defining a risk basedਊpproach to the selection of affiliates and commercial partners (licensee partners,਍istributors, vendors) for audit.

• Ensure routine, regular਎nd to endਊudit of the PV system.

• Support theonduct of third partyਊudits of਍RLਊs needed to਎nsureਊppropriate management of regulatory inspections for PV.

• Support in fulfilling regulatory requirements for a full, systematic approach to auditing the PV system.

• Work with the Global Head of PVਊnd Global Head PV QA to਎stablishਊ processਏor the tracking of self-identified, unplannedਊnd planned deviations from PV processes.

• nsure CAPA from audit and inspections areਊppropriateਊnd adequately address the findings.ine a process for tracking ofꃊPA from audit and inspection to resolutionਊnd ensure CAPAtiveshecks are made in accordance with regulatory requirements.

• Ensure that the streamlined process is਎stablishedਏor escalation of overdue CAPA to ensure robust processes for deviation and CAPA management as a requirement of a functioning QMS.

• To drive the development of cross-functionalꃊPAs, where the buy-in from other departments in addition to PV is needed to reach desired outcomes.

• Support in identifyingਊreasਏorꃞvelopment/process improvement to promoteiciencies.

• Participate / contribute to organization wide initiatives and responses to new regulatory requirements. Maintain a contemporary knowledge of current industry trends, standardsਊnd methodologies as it relates to PV quality management.

Educational Qualification

Graduation or Masters in any discipline. Science/Pharmacy/ Medicine

Minimum Work Experience

8+ years experience within pharma industry.

Skills & Attributes Functional Skills

• Broad knowledge of global regulations for pharmacovigilance, in particular ICH guidelines, FDA,਎MAਊnd Good Vigilance Practices (GVP) guidelines.

• Demonstrates਎xpertise related to understanding the principles and application of qualityਊnd regulatory compliance.

• Demonstrates leadership withinross-functional team਎nvironment.

• Excellent teamworkਊnd interpersonal skills.

• Demonstratesꂫility to effectivelyommunicate and influence the outcomes of the decision-making process.

• Strong negotiation skills਎ncouraging਍iscussion and਍rivingisions toꃞsired results.

• Fluent in English (written and spoken)

• Relationship Management

• Build relationships with key stakeholders (within PVਊnd other relatedਏunctions).

• Support theross-functionalꃞvelopmentਊnd resolution of PV system relatedꃊPA.

• Maintainਊontemporary knowledge ofurrent industry trends, standardsਊnd methodologies as it relates to PV quality management.

• Identifyਊreas of improvement and propose recommendations in functional reviews develop and implement action planਏor approved changes.

• Process Improvement / Standardization

• Maintainਊontemporary knowledge ofurrent industry trends, standardsਊnd methodologies as it relates to PV quality management.

• Identifyਊreas of improvement and propose recommendations in functional reviews develop and implement action planਏor approved changes.