Sr.Manager/Associate Director in Cambridge, MA at DISYS

Date Posted: 6/28/2018

Job Snapshot

Job Description

Job Description:


 


Objective:
• Support oversight of Pharmacovigilance activities in Clinical Trials 
• Ensure compliance with global pharmacovigilance requirements 
• Support GCP and PV inspections and audits 
• Through oversight of outsourced activities, ensure all Pharmacovigilance Lead activities are executed consistently throughout all Pre and Post-approval Clinical Studies globally 

Accountabilities: 
The Sr. Manager/Associate Director is responsible for: 
• Supporting partner / vendor oversight in relation to Clinical Trial Pharmacovigilance Operations and collaboration with other functions (e.g., Clinical Operations, Global Medical , Data Management, Medical Writing, Regulatory, Biostatistics, and others ) to ensure consistency with regulations and with departmental goals and objectives. 
• Ensuring regulatory compliance with safety regulations globally 
• Ensuring Takeda fulfils the pharmacovigilance obligations for its global programs 
• Ensuring productive and effective collaboration across functions responsible for clinical trial delivery 
• Liaising with the relevant lead product safety MD as appropriate 
• Ensuring timely support for safety issues & enquiries impacting global programs 
• Supporting strategies for Takeda compliance with relevant Regulatory Agencies on pharmacovigilance requirements and gaining consensus within Global PV Safety 
• Ensuring effective co-ordination of trial safety logistics globally, drawing input from relevant lead product safety physicians and trials safety managers 
• Monitoring Purchase Orders and ensuring that invoices from vendors are within the scope of the budgeted activities. 
• Contributing to the development and maintenance of pharmacovigilance processes for Takeda 
• Supporting and maintaining a state of inspection readiness 

Scope Of Supervision: 
NUMBER SUPERVISED WORKERS Direct In-Direct 
Employees 0 TBD 
Non-Employees 0 TBD 

Education, Behavioral, Competencies And Skills: 
• Bachelor’s degree required. Advance degree preferred. 
• Substantial pharmaceutical or health care related industry experience required 
• Must have significant Clinical Trial Operations experience (PV experience is highly preferred) including experience working with CROs, vendors, and relationship management. 
• Demonstrated skills in negotiation and consensus decision making 
• Expert knowledge of clinical trial and pharmacovigilance methodologies preferred. 
• Critical thinking and analytical skills and ability to make and communicatre high level decisions or complex data in cross-functional and global environments. 
• 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. 
• Multi-tasking with the ability to successfully manage multiple critical issues simultaneously 
• Demonstrates integrity 
• Project Management abilities 
• Excellent ability to work under high pressure and to manage both time and priority constraints and to manage multiple priorities simultaneously 
• Attention to details, computer literacy, knowledge of EDC 
• 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 

Physical Demands: 
• Routine demands of an office based environment. 

Travel Requirements: 
• Some travel within Takeda global sites may be required.



Warm Regards,


Aravindarajan


Technical Recruiter


Digital Intelligence Systems (DISYS)


Phone: 972-776-6775  | www.disys.com


Email: aravind.pandiarajan@disys.com

Job Requirements

Job Description:


 


Objective:
• Support oversight of Pharmacovigilance activities in Clinical Trials 
• Ensure compliance with global pharmacovigilance requirements 
• Support GCP and PV inspections and audits 
• Through oversight of outsourced activities, ensure all Pharmacovigilance Lead activities are executed consistently throughout all Pre and Post-approval Clinical Studies globally 

Accountabilities: 
The Sr. Manager/Associate Director is responsible for: 
• Supporting partner / vendor oversight in relation to Clinical Trial Pharmacovigilance Operations and collaboration with other functions (e.g., Clinical Operations, Global Medical , Data Management, Medical Writing, Regulatory, Biostatistics, and others ) to ensure consistency with regulations and with departmental goals and objectives. 
• Ensuring regulatory compliance with safety regulations globally 
• Ensuring Takeda fulfils the pharmacovigilance obligations for its global programs 
• Ensuring productive and effective collaboration across functions responsible for clinical trial delivery 
• Liaising with the relevant lead product safety MD as appropriate 
• Ensuring timely support for safety issues & enquiries impacting global programs 
• Supporting strategies for Takeda compliance with relevant Regulatory Agencies on pharmacovigilance requirements and gaining consensus within Global PV Safety 
• Ensuring effective co-ordination of trial safety logistics globally, drawing input from relevant lead product safety physicians and trials safety managers 
• Monitoring Purchase Orders and ensuring that invoices from vendors are within the scope of the budgeted activities. 
• Contributing to the development and maintenance of pharmacovigilance processes for Takeda 
• Supporting and maintaining a state of inspection readiness 

Scope Of Supervision: 
NUMBER SUPERVISED WORKERS Direct In-Direct 
Employees 0 TBD 
Non-Employees 0 TBD 

Education, Behavioral, Competencies And Skills: 
• Bachelor’s degree required. Advance degree preferred. 
• Substantial pharmaceutical or health care related industry experience required 
• Must have significant Clinical Trial Operations experience (PV experience is highly preferred) including experience working with CROs, vendors, and relationship management. 
• Demonstrated skills in negotiation and consensus decision making 
• Expert knowledge of clinical trial and pharmacovigilance methodologies preferred. 
• Critical thinking and analytical skills and ability to make and communicatre high level decisions or complex data in cross-functional and global environments. 
• 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. 
• Multi-tasking with the ability to successfully manage multiple critical issues simultaneously 
• Demonstrates integrity 
• Project Management abilities 
• Excellent ability to work under high pressure and to manage both time and priority constraints and to manage multiple priorities simultaneously 
• Attention to details, computer literacy, knowledge of EDC 
• 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 

Physical Demands: 
• Routine demands of an office based environment. 

Travel Requirements: 
• Some travel within Takeda global sites may be required.



Warm Regards,


Aravindarajan


Technical Recruiter


Digital Intelligence Systems (DISYS)


Phone: 972-776-6775  | www.disys.com


Email: aravind.pandiarajan@disys.com

Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.