Project Manager, Risk Management
Location: Chicago Illinois
Description: Pharmacists Association is currently seeking to employ Project Manager, Risk Management right now, this job will be placed in Illinois. Further informations about this job opportunity kindly read the description below. Job Details
Project Manager, Risk Management, Chicago, IL
Job Title:
Project Manager, Risk Management
Location:
Chicago,
Illinois
Date Posted:
12/7/2013
Full Time/Part Time: Full Time
Permanent/Temporary:
Regular
Employment/Contract Work:
Employment
Visa Waiver Available:
No
Job #: 1463976
AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company f! ormed in 2013 following separation from Abbott. AbbVie combine! s the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world's most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.
Project Manager, Risk Management/Minimization
This individual will be a part of the Risk Management group within the Global Pharmacovigilance organization.
Responsibilities
Develop and manage project plans with accompanying timelines for risk management activities, including development and implementation of risk minimization / REMS tools, evaluations of the tools / risk minimization program, and risk minimization metrics tracking as appropriate.
Develop and manage project plans with accompanying timelines for risk management publication plans. Define, plan, and implement risk managemen! t strategies that are aimed at achieving optimum benefit-risk for products throughout the lifecycle of the drug.
Assists with strategic planning for development and/or revision of risk management plans (RMPs), risk minimization / REMS process workflow development, SOPs, and audit/inspection support.
Track and ensure execution against project plans and initiate corrective actions to bring plan back to schedule.
Manage funding and contracts for risk management activities
Maintains current knowledge of evolving international safety surveillance and risk management regulations. Ensure that GPV safety risk management processes are continuously improved to reflect regulatory trends and guidelines, represent best practice, and are aligned with the global governance model.
With the Head Risk Management, coordinate operation of Risk Management team meetings.
Ensure all core risk minimization tools and risk minimization evaluations as ! appropriate are submitted to the AbbVie internal review process for non! -promotional materials.
Manage inventory and activity tracker for Risk Management group.
Ensure Risk Management group metrics are defined and captured per governance.
Serve as the Risk Management group representative to audit corrective action preparation team. Prepare corrective action plans as appropriate.
Provide general administration for the creation and distribution of canned and ad hoc reports (e.g. reports to upper management).
Manage the documentation and archiving of Risk Management deliverables per standards and templates.
Prioritize project issues, refocus objectives and propose resolutions to Head Risk Management for course correction.
Serve as back-up to Affiliate Risk Management System (AFFIRMS) Administrator, to ensure facilitation of local risk minimization activities, distribution of core material and tracking of risk management initiatives.
Effectively identify department and division need! s, problems, and successfully presents them to management. Assist management with strategic planning and department/division development.
Reinforce and align with the principles of the Project Safety Team model.
Participates in risk management planning as appropriate to support regulatory agency submissions.
Participate in quality improvement efforts to enhance risk management support to affiliates (such as development of processes systems, templates, procedures).
Collaborate with Education and Training group to facilitate development of PV specific Risk Management curriculum and training.
Education/Experience/Skills
Bachelor's degree with related health science background, BSN, BS, BS Pharm, PharmD. Advanced degree preferred. 5 + years pharma experience, with 2-3 years project management experience required, including management of large, complex projects.
Qualifications:
- Competent in projec! t management tools and techniques.
- Experienced in managing cro! ss-functional teams.
- Experienced in managing large complex projects / programs and multiple projects simultaneously.
- Advanced understanding of ICH, EU and US Pharmacovigilance and Risk Management requirements.
- Apply Medical, Therapeutic, and Regulatory knowledge to assist in sound decision making regarding Risk Management activities, safety issues and department priorities.
- Back-up system owner of risk management office electronic tools and databases; understands Part 11 compliance and validation requirements.
- Proven ability to effectively lead cross-functional teams with respect to risk management activities and ability to establish collaborative working relationships in managing multiple projects and deadlines.
- Strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across functions and teams
- Able to build relationships with diverse stakeholders (inclu! ding affiliates)
- Knows when to elevate issues to management.
- Strategic thinking and results-oriented performance.
- Solid organizational abilities and time management skills
Conferences
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Pharmacists Association.
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This job starts available on: Tue, 10 Dec 2013 06:51:25 GMT