Job Order: 4601
Staff Representative: Tim Jadwin
Position: Team Manager Pharmacovigilance - Team Clinical
Location: Illinois
Company Summary:
Our client, a large pharmaceutical company, is dedicated to serving patients by providing innovative products that improve their lives with better healthcare. With a foundation built on a robust, early-stage pipeline, our client is a world class pharmaceutical company.
Description:
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.
- 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.
- 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 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
- Estimated 5-10 times per year outside the area including possible international travel.
