Pharmacovigilance Manager - Safety Reporting

1+ years

Not Disclosed

Remote Remote - Europe Remote Australia Remote Korea Remote, USA

10 Dec. 11, 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

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

Job Description:

Join Thermo Fisher Scientific Inc. as a Pharmacovigilance Manager and play a critical role in ensuring patient safety while working in an innovative and collaborative environment. This opportunity allows you to support exceptional research initiatives and be part of a team dedicated to making a global impact on patient care and safety.

Job Responsibilities:

Discover Impactful Work:

Manage contracted safety responsibilities for multiple programs, overseeing staffing, training, and procedural compliance.
Lead the safety team for respective programs and ensure the development of internal processes aligned with best practices.
Collaborate with senior management and liaise proactively with Project Managers and clients to optimize safety project team performance.

A Day in the Life:

Monitor and evaluate risks to pharmacovigilance (PV) project deliverables and finances; propose effective mitigation strategies.
Serve as the primary point of contact for clients, managing relationships and communication.
Oversee financial stewardship, guiding decisions for project scope increases and driving profitability.
Drive timelines and tasks related to safety reporting PV functions, ensuring deadlines and deliverables are met.
Lead operational, tactical, and governance calls with clients.
Prepare for and attend client audits and inspections.
Maintain coordination with other teams regarding project issues and topics.
Generate key performance metrics for projects, such as key performance indicators and volumes.
Oversee the budget for assigned projects, collaborating with teams on contract management and renewals.
Lead internal financial and project review meetings.
Ensure collaboration across all PV functions to meet agreed project targets.
Drive departmental initiatives for continuous improvement.

Education:

Bachelor's degree or equivalent and relevant formal academic/vocational qualifications.
3+ years of safety experience, with a minimum of 8 years of relevant work experience.
1+ year of leadership responsibility, with demonstrated ability to lead and manage teams.

Knowledge, Skills, and Abilities:

Ability to apply knowledge and skills in a highly organized manner, adhering to relevant regulations, global SOPs, and client expectations.
Broad understanding of pharmacovigilance processes and global regulatory requirements.
Proficiency in Microsoft Office products and safety databases.
Excellent command of English with the ability to translate information when necessary.
Exceptional oral and written communication skills, with strong attention to detail and accuracy.
Strong critical thinking, problem-solving, and decision-making abilities.

Why Join Us?

At Thermo Fisher Scientific, we share a set of core values—Integrity, Intensity, Innovation, and Involvement. Be part of a global team working together to advance scientific research and improve patient outcomes worldwide.

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Pharmacovigilance Manager - Safety Reporting

Job Description

Job Description:

Job Responsibilities:

Discover Impactful Work:

A Day in the Life:

Education:

Knowledge, Skills, and Abilities:

Why Join Us?

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