Sr. Manager/Associated Director, Clinical Trial PV Ops III
Position Title: Sr. Manager/Associated Director, Clinical Trial PV Ops III
Duration: 1 Year Assignment eligible for extension or renewal
Location: Cambridge, MA
* 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
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
EDUCATION, BEHAVIOURAL 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
Sthree US is acting as an Employment Business in relation to this vacancy.