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Job Description
Senior Manager, Pharmacovigilance
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence.
Our people are our greatest strength, and the driving force behind our success. We help to accelerate the development of drugs and devices that save lives and improve quality of life.
Job Summary:
Monitors projects to assure company profitability and associated project goals and objectives are being met. Develops, implements, and monitors profitability, objectives, metrics of assigned group of direct reports.
- Monitors projects to assure company profitability and associated project goals and objectives are being met.
- Develops, implements, and monitors profitability, objectives, metrics of assigned group of direct reports.
- Identifies and implements improvements of processes within own service area through review of project specific plans and their implementation.
- Manages resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligations.
- Analyzes current and future project backlog in order to provide adequate resources to meet business objectives.
- Provides technical oversight of the generation of project plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans.
- Delivers training on department related topics as well as general company processes and systems to Pharmacovigilance staff.
- Liaises with other functional managers to ensure consistency of pharmacovigilance approaches within the company.
- Maintains familiarity with current industry practices and regulatory requirements that affect services provided by the assigned service area.
- Reviews Pharmacovigilance Associate, Pharmacovigilance Specialist and/or Pharmacovigilance Assistant group-related project tasks.
- Supports direct reports in identification of out of scope activities and process efficiency/improvement needs.
- Ensures that staff fulfill their responsibilities in accordance with company and/or client QMS, policies, procedures, and SOPs.
- Creates an environment that encourages learning, self-improvement and career development for staff.
- Identifies and implements process improvements through review of SOPs, processes.
- Builds teamwork and improves process and productivity by working within and across functional areas.
- Ensures staff development and performance feedback are provided through activities such as mentorship and career development.
- Involved in the recruiting processes for new employees within the assigned service area.
- Assists with bringing new business opportunities to the company and maintaining existing clients' relationships for repeat business.
- Interacts with clients and participates in client meetings as necessary to support and maintain new business.
- Participates in business development initiatives, including presentations and proposal development.
- Ensures that timely and accurate information is submitted on all proposal efforts.
- Supports direct reports and senior management during audit preparation and conduct.
- Responds to audit findings as needed.
- Coordinate interdepartmental activities (e.g. quality control processes, quality assurance (audits), miscellaneous project activities).
- Acts as a Subject Matter Expert (SME) for various technologies or processes.
- Develops and delivers training courses on Pharmacovigilance related topics to ICON employees within and outside Pharmacovigilance.
- Displays an industry presence by writing articles for industry publications, giving presentations at industry conferences, and obtaining industry certifications.
Requirements:
- Thorough working knowledge of local and global medical device Health Authority regulations, guidelines, policies and ICH Guidelines.
- Effective project management skills.
- Ability to make decisions independently and operate autonomously.
- Excellent Planning, organization, people, time and change management skills.
- Ability to develop and maintain good rapport with the clients.
- Highly motivated and proactive.
- Ability to organize the team in a way to ensure stable and easy scale up of the structure.
Benefits:
- Work From Home