Executive Director, Pharmacovigilance, Safety Technical Operations, Emea

7+ years

Not Disclosed

Remote Remote Australia Remote - Europe Remote Korea Remote, USA

10 Dec. 11, 2024

Job Description

Job Type: Full Time 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

Job Title: Director of Pharmacovigilance Operations
Location: Not Specified
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office

Job Description:

At Thermo Fisher Scientific, you’ll find meaningful work that makes a positive global impact. Join our mission to make the world healthier, cleaner, and safer. We provide our teams with the resources they need to achieve individual career goals while advancing science through research, development, and delivery of life-changing therapies. With clinical trials conducted across 100+ countries, our work spans laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will help improve health outcomes globally, for today and the future.

Summarized Purpose:

The Director of Pharmacovigilance Operations ensures the operational excellence of the department by providing strategic leadership and oversight. This role involves guiding and mentoring staff across various specialty areas, driving key initiatives, and collaborating with senior leadership to achieve operational and financial success. The Director will identify business opportunities, manage department projects, and work with internal stakeholders to drive enterprise-wide initiatives that align with business objectives.

Key Responsibilities:

Leadership and Staff Management:

Manage staff, including hiring, professional development, performance management, and coaching/mentoring.
Approve salary administration, hiring decisions, corrective actions, terminations, and time records.
Promote Equal Employment Opportunity and Affirmative Action policies.
Provide leadership and technical expertise to business-critical structures.
Manage and develop staff across multiple functional areas.

Strategic Planning and Business Development:

Lead PV technology strategy and development to support clients’ needs.
Drive business development efforts, including writing and reviewing proposals, presenting capabilities to clients, and fostering client relationships.
Represent the organization during external FSP governance meetings.
Oversee budget management and long-term forecasting, ensuring excellence in performance and resource allocation.

Risk, Compliance, and Process Improvement:

Manage and maintain PV systems and processes to ensure compliance with regulatory requirements.
Drive the adoption of innovative solutions to enhance PV operations and processes.
Manage risks and challenges associated with PV integration, particularly during mergers and acquisitions.

Cross-functional Collaboration:

Collaborate with senior leadership to develop policies and strategic plans, assess opportunities, and manage risks.
Liaise with internal teams and clients to align efforts and ensure smooth PV operations.

Education and Experience:

15+ years of relevant experience in pharmacovigilance operations.
8+ years of management experience, with a proven record in leading high-performing technical teams.
Extensive experience in overseeing PV systems and compliance with regulatory requirements.
Expertise in strategic planning, business growth, and the drug development lifecycle.
Strong background in regulatory compliance, GCPs, FDA/ICH guidelines, and international regulatory authorities.

Knowledge, Skills, and Abilities:

Strong leadership skills, with the ability to influence in matrix environments.
Extensive knowledge of PV systems and regulatory requirements.
Expertise in strategic planning, fiscal management, and resource allocation.
Proven ability to negotiate, influence executives, and lead cross-functional teams.
Change management experience with the ability to build motivated teams delivering high-quality results.

Management Role:

This senior management position involves global or regional responsibilities or management across multiple departments. The Director may also focus on a functional area and will be held accountable for leading and driving high-impact business objectives.

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