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Associate Director PV Sciences

Takeda Pharmaceuticals

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Location: Chicago, IL Posted Date: 5/6/2013 Position Type: Full time Job Code: 1300226 Required Education: Bachelors Degree

Description

OBJECTIVE:

This position is responsible for oversight of activities, timelines, and cross functional coordination for documents coming from PV, including regulatory submissions and responses, aggregate reports, white papers, etc.  The position is also responsible for Global oversight and supervision of PV specialists who support the above mentioned activities, including ensuring adequate resourcing and communication. Global leader of PV science in a single therapeutic area.   Provides strategic and technical expertise and leadership. Significant global management role. Supervises PV Scientists, and interfaces cross-functionally within PV and outside of PV.

ACCOUNTABILITIES:

* Leads PV science in a single therapeutic area.

* Provides strategic and technical expertise and leadership.

* Significant global management role. Supervises PV Scientists, and interfaces cross-functionally within PV and outside of PV.

* Leads PV Scientists' contribution to clinical program and protocol design, safety risk management, signal detection.

* Oversees all PV reports and submissions in designated therapeutic area(s), e.g., aggregate reports and regulatory submissions.

* Works closely with the PV Therapeutic Area Medical Lead.

* In collaboration with the PV TA Lead, leads evaluation and management of emergent safety issues.

* Ensures adequate internal support and external resourcing (CRO. BPO) to deliver all safety reports.

* Ensures adequate distribution of assignments and prioritization of tasks within the PV specialists staff.

* Interfaces with functional areas within and outside PV.

* Manages all PV Specialists in all regions ensuring adequate collaboration with GSTs and with teams writing and compiling aggregate reports and all documents produced by PV.

Requirements

EDUCATION, EXPERIENCE AND SKILLS:

* Degree level qualification (e.g. Bachelors degree) in scientific/medical field and higher degree or specific pharmacovigilance qualification preferred.

* Minimum 9 years experience in pharmacovigilance with significant experience in preparing regulatory documents.

* Firm Pharmacovigilance background amp; understanding of PV process in aggregate submissions and the new regulations that have been established.

* Demonstrated experience in people management and well-developed skills in teambuilding, motivating and developing people.

* Expert knowledge of clinical trial and pharmacovigilance methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements

* Excellent organization skills and ability to prioritize individual and team work loads.

* Excellent written and oral communication skills including ability to present to large internal/external groups

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
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