Job Description

• The Director, Clinical Trial PV Operations will provide functional expertise and Program level oversight of outsourced PV Activities globally, including set up and conduct of clinical studies from a PV perspective, CRO training and management.
• Partners with key stakeholders within and outside PV to ensure continuous harmonized operations of global Pharmacovigilance activities and maintain highest standards for integrated functioning.
• Responsible for overall leadership to support global principles and standard practices for PV operational activities within clinical trials.
• Identify potential cross TA issues/risks in a proactive matter and lead discussions to mitigate them
• Be proactive in identifying any process gaps across TA and propose well thought out solutions and drive those solutions to implementations

Accountabilities:
(Describe the primary duties and responsibilities of the job.Approximately 5 10 bulleted task statements should be identified).

• Oversee outsourced PV Activities supporting clinical Trials at the clinical program level
• Perform oversight tasks of daily study specific activities including SAE reconciliation, stud set up, query management, SAE reconciliation, eTMF filing etc.
• Support study specific Inspection and Audit requests
• Build and foster cross functional relationships to promote and support PSPV standards
• Influence others and work collaboratively across functions to align on best practices and processes
• Conduct sample quality review of outsourced activities including SAE Reconciliation, eTMF filling, SAE Forms and completion instructions, protocol safety section etc.
• Review Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation Plans
• Maintain direct contact with the study PV Operations Lead at the vendor to proactively identif risks and issues
• Support Study/program specific Audits and Inspections related to PV Operations
• Maintain knowledge of PV Regulations and global industry practices for PV operationa efficiency and compliance
• Liaise with and advise study teams including clinical Science, Data Management, Regulatory Affairs and other functional areas locally/globally on matters relating to Pharmacovigilance to ensure overall compliance and appropriate standards and methodologies within the company
• Ensure consistency in collection, processing and evaluation of safety data, to drive
  improvements in Client global processes.
• Represent Pharmacovigilance Operations on global Program/study teams

Education, Behavioural Competencies And Skills:
(List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be highlighted.)

• Bachelor s required. Degree in scientific/medical field or advanced degree preferred
• Demonstrated skills in negotiation and consensus decision making
• Expert knowledge of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements.
• Good cross-cultural understanding and experience
• Critical thinking and analytical skills and ability to make high level decisions in cross- functional and global environments.
• Ability to review, analyse, interpret and present complex data to a high standard
• Understanding of and contribution to Takeda business needs and global strategy
• Able to interact with personnel from all functional areas and externally to the company at all levels and to represent the department and company in a highly professional manner.
• Good level of computer literacy with Microsoft applications
• Excellent organisation skills and ability to prioritize individual and departmental workloads.
• Multi-tasking with the ability to successfully manage multiple critical issues simultaneously
• Take the initiative to patriciate in projects outside the direct remit of the job to enhance visibility of the department and ensure cross functional awareness of PSPV processes and standards

Licenses/Certifications:
Physical Demands:

• (Identify any physical demands required in the performance of the primary responsibilities of the position).

Travel Requirements:

• Some travel to global client sites may be required.

Additional Us Specific Information (For Us Recruitment Only):

• Minimum 12 years pharmaceutical or health care related industry experienced required;previous experience working in global environment preferred.
• Minimum 10 years experience in Pharmacovigilance
• Minimum 7 years experience working with CROs, vendors, and relationship management preferred.

Additional Europe Specific Information (For European Recruitment Only)

• This section should reiterate minimum/essential requirements for role

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