Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
- Develops career plans for direct reports. Develops strong performance objectives for team that are closely aligned to Global Data Management and Standards(GDMS) organization’s goals, makes work assignments, conducts periodic skill assessments as well as annual performance appraisals, coaches for performance, provides ongoing feedback on performance, provides rewards and recognition, and sets priorities
- Provides developmental opportunities for direct reports, including stimulating growth assignments. Develops promotion strategies and prepares promotion recommendations. Ensures direct reports receive appropriate training and mentoring to be successful in their assignments
- Participates in the recruitment process and may recommend termination
- Aligns others around a positive direction. Develops challenging but achievable objectives that clearly promotes stated organizational goals.
- Maximizes staff effectiveness by working with direct reports to ensure a realistic workload that supports work-life balance, estimating length and difficulty of tasks and projects, anticipating and adjusting for obstacles and setbacks, and elevating complex issues to the appropriate management level
- Assumes specific functional management tasks for business deliverables assigned to direct reports or supervised staff on project
- Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, imparting best practices and directing continuous improvement efforts
- May serve as a functional area head with tasks for establishing Standard Operating Procedures and other business practices for that area (including management of an operating budget) *
- May supervise contingent, non-exempt, or temporary workers, on-shore and offshore
- Establishes, collects, and interprets performance metrics. Identifies correction strategies and ensures they are implemented accordingly. Manage performance. Conducts management and functional area meetings, contributing expertise when necessary through formal or informal presentations *
- Keeps abreast of process, technology and regulatory changes both within and outside of our company that may impact staff. May participate in or guide initiatives beyond GDMS (e.g. cross-divisional projects, cross-industry initiatives, etc.) May support any other project or perform any other data management or drug surveillance task deemed appropriate by management.
B.A. or B.S. degree in relevant discipline.
Knowledge and Skills:
Minimum 6 years’ experience in Clinical Data Management or Pharmacovigilance as appropriate to business role or related industry experience preferred, at least 3 years of supervisory or management experience
Strong knowledge of the Drug Discovery or Drug Surveillance Process, ICH and GCP guidelines
Knowledge of database structures and available tools to manage, extract, and report data
Basic knowledge of statistical concepts
Strong organizational, time management, problem solving and project coordination skills
Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business areas
Strong sense of urgency and leadership. Ability to present in a group environment
Ability to direct a team
Ability to be flexible, multi-task and work independently
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.