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Senior Manager, Pharmacovigilance

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ICON plc

3mo ago

  • Job
    Full-time
    Senior & Expert Level
  • Research & Development
    Healthcare
  • Dublin
  • Quick Apply

AI generated summary

  • You need knowledge of medical device regulations, strong project management skills, independence, excellent organizational abilities, client interaction experience, motivation, and team scaling skills.
  • You will manage projects, ensure profitability, develop training, oversee processes, support audits, enhance efficiencies, and foster client relationships while guiding your team in pharmacovigilance.

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; experience with client interactions is advantageous
  • Highly motivated and proactive
  • Ability to organize the team in a way to ensure stable and easy scale up of the structure

Responsibilities

  • Monitors projects to assure company profitability and associated project goals and objectives are being met.
  • May serve as the main point of contact for the customer for the life-cycle of assigned stand alone projects and programs, and the main pharmacovigilance point of contact for assigned full-service projects.
  • 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; recommends improvement plans to projects.
  • 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.
  • Identifies and implements process improvements and other ways to improve efficiencies.
  • Provides technical oversight of the generation of project plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans, in close cooperation with project team during set-up phase.
  • 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; provides leadership in the delivery of related services to clients.
  • Supports direct reports in identification of out of scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required.
  • Ensures that staff fulfill their responsibilities in accordance with company and/or client QMS, policies, procedures, and SOPs, as applicable.
  • Creates an environment that encourages learning, self-improvement and career development for staff.
  • Identifies and implements process improvements through review of SOPs, processes; recommend improvement plans to senior management.
  • 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).
  • Acting 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, as well as to external parties (investigators, clients).
  • Displays an industry presence by:
  • Writing articles for industry publications.
  • Giving presentations at industry conferences.
  • Obtaining industry certifications.
  • Represents the assigned Pharmacovigilance service area as part of global initiatives impacting Pharmacovigilance, and makes decisions autonomously, with little direct supervision required.

FAQs

What is the primary responsibility of the Senior Manager, Pharmacovigilance at ICON plc?

The primary responsibility includes monitoring projects to ensure company profitability and that associated project goals and objectives are being met.

What qualifications are necessary for the Senior Manager, Pharmacovigilance position?

Candidates should have a thorough working knowledge of local and global medical device Health Authority regulations, effective project management skills, and the ability to operate autonomously.

Does the Senior Manager role involve client interactions?

Yes, the role may serve as the main point of contact for clients for the lifecycle of assigned standalone projects and programs.

What kind of process improvements are expected in this role?

The Senior Manager is responsible for identifying and implementing improvements to processes within their service area and recommending improvement plans to projects.

Are there opportunities for professional development and training in this position?

Yes, the Senior Manager is expected to provide training on department-related topics and create an environment that encourages learning and career development for staff.

What kind of team management is involved in this role?

The Senior Manager is responsible for managing resources, developing a stable and scalable team structure, and ensuring team performance and development.

Will the Senior Manager participate in business development initiatives?

Yes, the role involves participating in business development initiatives, including presentations and proposal development.

What kind of benefits does ICON plc provide to employees?

ICON offers a comprehensive and competitive total reward package, including competitive salaries, health insurance, retirement planning, and various wellbeing initiatives.

Is the company committed to diversity and inclusion?

Yes, ICON plc is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.

Are there flexible working options available for this role?

Yes, there are flexible country-specific optional benefits that may include work-life balance opportunities for employees and their families.

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ICON plc

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.