Senior Manager, Pharmacovigilance

5+ years

Not Disclosed

Remote, USA

10 Aug. 8, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the Role

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. With patients at the center of all that we do, we help accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Role: Project Manager - Pharmacovigilance

Description:

Monitor projects to ensure company profitability and achievement of project goals and objectives.
Serve as the main point of contact for customers throughout the lifecycle of assigned standalone projects and programs, and as the primary pharmacovigilance contact for assigned full-service projects.
Develop, implement, and monitor profitability and objectives for assigned team members.
Identify and implement process improvements within the service area through reviewing and improving project-specific plans.
Manage resources and projections to ensure project teams meet client needs, expectations, and contractual obligations.
Analyze current and future project backlog to provide adequate resources for business objectives.
Provide technical oversight during the generation of project plans, such as Safety Management Plans (SMP) or SAE Reconciliation plans, in cooperation with the project team during setup.
Deliver training on department-related topics and general company processes and systems to Pharmacovigilance staff.
Liaise with other functional managers to ensure consistency in pharmacovigilance approaches.
Stay updated on current industry practices and regulatory requirements affecting the service area.
Review project tasks of Pharmacovigilance Associates, Specialists, and Assistants; provide leadership in delivering services to clients.
Support direct reports in identifying out-of-scope activities and implementing process efficiency improvements or contract amendments as required.
Ensure staff adhere to company and client Quality Management Systems, policies, procedures, and SOPs.
Create an environment that encourages learning, self-improvement, and career development for staff.
Identify and implement process improvements by reviewing SOPs and processes; recommend improvement plans to senior management.
Build teamwork and improve productivity by working within and across functional areas.
Ensure staff development and performance feedback through mentorship and career development activities.
Participate in recruiting processes for new employees within the service area.
Assist with securing new business opportunities and maintaining existing client relationships for repeat business.
Interact with clients and participate in client meetings to support and maintain new business.
Participate in business development initiatives, including presentations and proposal development.
Ensure timely and accurate information submission on all proposal efforts.
Support direct reports and senior management during audit preparation and conduct; respond to audit findings as needed.
Coordinate interdepartmental activities, including quality control processes, quality assurance (audits), and miscellaneous project activities.
Act as a Subject Matter Expert (SME) for various technologies or processes.
Develop and deliver training courses on Pharmacovigilance topics to ICON employees and external parties (investigators, clients).
Maintain an industry presence by writing articles for industry publications, giving presentations at industry conferences, and obtaining industry certifications.
Represent the Pharmacovigilance service area in global initiatives impacting Pharmacovigilance, making autonomous decisions with minimal supervision.

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 clients; experience with client interactions is advantageous.
Highly motivated and proactive.
Ability to organize the team to ensure stable and easy scaling of the structure.

Benefits of Working at ICON:

Our success depends on the knowledge, capabilities, and quality of our people. We are committed to developing our employees in a continuous learning culture, challenging you with engaging work, and ensuring every experience adds to your professional development.

At ICON, we provide a comprehensive and competitive total reward package, which includes an excellent base pay level and a wide range of variable pay and recognition programs. Our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now and in the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If, due to a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please let us know through the form below.