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Company

Original Job Post

myGwork - LGBTQ+ Business Community · 2 days ago

Liaison Manager, Pharmacovigilance

Massachusetts, United States

Full-time

Onsite

Senior Level

8+ years exp

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Responsibilities

Increase the visibility of the team/function with focus on US and Canada

Ensure strategic pharmacovigilance support in the region to Regulatory Affairs, Medical Affairs, US Commercial function, and the broader organization as required to contribute to enhancing global patient safety awareness.

Participate in health authority interactions throughout the product life-cycle as needed. Closely collaborate with other functions including regulatory, medical, communications, quality, legal, as well as other teams within Development.

Progress understanding and education of safety requirements for pharmacovigilance and other relevant regulations cross-functionally to ensure patient safety and compliance with requirements.

Develop relationships across the organization as it relates to adverse event reporting and other pharmacovigilance activities.

Maintain an in-depth knowledge of FDA regulations, expectations, and regulatory authority contacts; and perform activities related to the interpretation and review of existing and evolving FDA safety requirements.

Lead and actively participate in audit and inspection readiness, support, and management together cross-functional teams.

Engage in due diligence activities as needed when potential business partnerships or collaborations may take place.

Contribute to departments issue management, recommend and implement action plans for mitigation

Identify opportunities to align PV standards globally.

Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development.

Contribute to the development and evaluation of Key Performance Indicators as related to pharmacovigilance in the region.

Transparently communicate and/or escalate issues to leadership as appropriate.

Drive Continuous Improvement initiatives as needed.

May perform other tasks as appropriate.

Qualification

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Pharmaceutical/biotech industry experiencePharmacovigilance/drug safetyDrug development knowledgeGXP qualityCompliance requirementsSafety business processesAdverse eventsDocument authoringMicrosoft OfficeEnglish fluencyOffice equipment proficiencyProject managementProblem solvingConflict resolutionCritical thinking presentation planningOrganizational skillsOral communicationWritten communicationMotivationInfluenceCollaborationIndependenceGlobal environmentAdaptabilityInterpersonal communicationStress managementAdverse Event MonitoringDigital/Social Media

Required

Master's degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)

8+ years of experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety

Knowledge of the drug development process, GXP quality and compliance requirements

Excellent presentation skills with the ability to communicate complex issues clearly

Excellent planning and organizational skills with ability to manage competing priorities

Excellent oral and written communication skills

Strong ability to motivate, influence, and collaborate with multidisciplinary teams

Ability to work independently and in a global environment

Understanding of safety business processes and systems for the collections of adverse events

Problem solving, conflict resolution and critical thinking skills

Demonstrated ability to author or contribute to complex documents

Relevant computer skills, including proficiency with Microsoft Office Suite

Fluency in written and spoken English

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner

Able to work upright and stationary for typical working hours

Ability to use and learn standard office equipment and technology with proficiency

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

Preferred

Experience with adverse event monitoring and reporting with digital/social media, market research, and relevant commercial and marketing related projects and programs

PharmD or MD degree

May require travel. (Recruiter will provide more details.)