Serving as the primary interface within Global PV for the coordination of activities related to global PV compliance and accountable for establishing and executing the PV compliance strategy worldwide excluding the EU/EEA and Japan territories
Principal responsibilities include:
- Ensuring the compliance activities related to PV inspection/audit readiness for Global PV and partnering with QA to determine internal PV audit areas of focus.
- Ensuring the oversight of the coordination of PV activities, PV SMEs, and PV deliverables during inspections and audits in coordination with the Head, PV EU/EEA Compliance &PSMF, EU QPPV and Head, Compliance, Japan PV as applicable
- Support both external and internal inspections and audits worldwide (except for Japan and EU/EEA territories).
- Collaborating with QA to ensure timely audit and inspection responses for the PV function and appropriate ownership of corrective and preventative action plans (CAPAs) by PV subject matter experts (SMEs) worldwide (except for Japan and EU/EEA territories).
- Collaborating with the Global PV functions to ensure compliance tracking processes and inspections and audit procedures/processes are in place that reflect alignment with various regulatory authorities regulations worldwide
- Ensuring that adequate process is in place to maintain current knowledge of compliance and relevant PV regulations, including evolving changes in the regulations that may impact compliance.
- Participating in and overseeing talent management strategies such as annual reviews, performance management, succession planning and employee development and retention.
Lead the global pharmacovigilance compliance group. Administer staff at local site for all Standards, Compliance & Training teams.
- Leads the development of PV compliance programs and quality tools to enhance global PV quality and adherence to SOPs and regulations audits in coordination with the Head, PV EU/EEA Compliance& PSMF and Head, Compliance, Japan PV as applicable.
- Ensures the execution and the development of adequate PV compliance processes by the designated Drug Safety Officers (DSO) at the Local Operating countries (LOCs) excluding in the EU/EEA and Japan territories.
- Collaborates with the Heads, DSO Relations EM PV and TPUSA PV PVAR to support inspections at LOC sites.
- Ensures that the PV compliance standard operating procedures and quality documents locally are aligned, consistent, and meet global requirements.
- Ensures execution of PV focused and related inspection/audit support globally audits in coordination with the Head, PV EU/EEA Compliance &PSMF and Head, Compliance, Japan PV as applicable.
- In conjunction with applicable Quality Assurance groups, ensure PV regulatory inspection and internal audit readiness for dedicated PV or GCP inspections/audits globally focused.
- Ensures that PV Compliance data is readily available for inspections and audit purposes.
- Ensures that all Global PV inspection and audit issues and findings are addressed adequately.
- Ensure appropriate identification of CAPA stakeholders owners within PV.
- Serve as the primary link to QA for escalation of PV CAPA compliance.
- Designs and implements appropriate mechanisms for maintaining and communicating compliance information focused across Global PV departments.
- Collaborates with QA and all relevant PV functions in the development and management of CAPA including assessment of root cause and establishment of timeframes.
- Directs and manages team to execute compliance activities as defined in a PV quality plan including maintenance, collection, compilation and regular assessment of adequate PV compliance metrics related but not limited to expedited and periodic PV regulatory reporting to relevant regulatory authorities for case processing and aggregate safety reporting, and their timely and adequate distribution to LOCs and PV business partners.
- Develops and implements PV systems in compliance with PV regulatory requirements worldwide in collaboration with the Global PV Standards
- Collaborates with the Global PV Training group in the development of training strategies to ensure that GPV processes meet PV compliance regulatory requirements worldwide.
- Escalates issues / problems related to PV compliance to senior management timely and as needed.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors Required. Advance degree preferred.
- Significant pharmaceutical or health care related industry experience required.
- Must have proven experience in PV environment with additional demonstrable experience in leading support of pharmacovigilance and/or GCP audits/inspections
- In depth knowledge and comprehension of pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
- Familiarity with inspections and audit procedures
- Works strategically to realise organizational goals
- Critical thinking and decision-making skills.
- Exercise independent judgment.
- Understanding Takeda business needs with global business perspective and professional attitude.
- Demonstrate integrity
- Motivate and empower others
- Work productively in a high pressure environment
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Knowledge of compliance international Regulations and ICH environment foundations
- Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
- Project Management abilities
- Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Attention to details, computer literacy, knowledge of safety database
- Take initiative and autonomous action
- Able to lead teleconferences and meetings
- Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills
- Some travel within Takeda global sites may be required.
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