Team Manager Pharmacovigilance - Team Clinical

OBJECTIVE:

Lead and manage team of Pharmacovigilance Senior Specialist and Lead Specialist staff to ensure effective pharmacovigilance project support for development and/or marketed products.

Contribute and assist in high level pharmacovigilance activities including risk/benefit and regulatory activities and interactions.

Provides pharmacovigilance functional area expertise and support for assigned developmental and/or marketed products in conjunction with pharmacovigilance physicians.



ACCOUNTABILITIES:

Line management of Pharmacovigilance Senior Specialist and Lead Specialist staff including development, appraisal and assisting in recruitment.

Mentoring and training for Pharmacovigilance Senior Specialist and Lead Specialist staff.

Liaise with Senior Director of Pharmacovigilance Operations to assign projects and to ensure effective distribution and use of team resources.

Input into strategic planning and development of departmental procedures.

Identification and appropriate escalation of issues within team or department to Director.

Represent pharmacovigilance department internally and external, including interfacing with regulatory authorities, in an effective and professional manner.

Perform accountabilities as per Pharmacovigilance Lead Specialist for any designated products.

Provide advice and output review to Pharmacovigilance Lead Specialist staff to support complex activities.

Perform Due Diligence.

In conjunction with pharmacovigilance physicians, provide input, including data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators.

Participate in, or lead, risk/benefit activities including pharmacoepidemiology review, clinical and safety database analyses, literature review and providing analysis of results.

Any other tasks assigned by Senior Director of Pharmacovigilance Operations to assist in departmental activities. REQUIREMENTS


EDUCATION, EXPERIENCE AND SKILLS:

Registered Nurse or Degree level qualification (e.g. Bachelors degree) or above in scientific/medical field

Minimum 6 years of experience in pharmacovigilance

Demonstrated ability in people management/supervision

Demonstrated skills in effective team building, negotiation and consensus decision making

Excellent databases skills including ability to perform advanced searches and understanding of data mining methodologies

Expert knowledge of clinical trial and pharmacovigilance methodologies including safety profile and risk/benefit analysis and broad working knowledge of global regulatory requirements

Critical thinking and analytical skills and ability to make high level decisions

Ability to review, analyze, interpret and present complex data to a high standard

Understanding Takeda business needs with global business perspective and professional attitude

Good level of computer literacy with Microsoft applications

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

TRAVEL REQUIREMENTS:

Estimated 5-10 times per year outside the area including possible international travel.

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