Regional Pharmacovigilance Senior Manager

argenx SE; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

A biopharmaceutical company is seeking a Regional Pharmacovigilance Senior Manager to ensure compliance with regulatory requirements and enhance processes. This remote role involves supporting the Head of Regional PV and collaborating with multiple teams. Candidates should have a Master's degree and extensive experience in the pharmaceutical or biotech industry, particularly in pharmacovigilance.

Qualifications

• Master’s degree in pharmacy, nursing or healthcare (PharmD or MD is a plus).
• At least 7-11 years of experience in pharmaceutical/biotech industry.
• Working knowledge of pharmacovigilance regulatory requirements.
• Knowledge of drug development process and compliance requirements.

Responsibilities

• Support harmonization of processes across regions.
• Manage innovation projects for Regional Team efficiency.
• Establish and maintain pharmacovigilance systems.
• Contribute to compliance with pharmacovigilance obligations.

Skills

Good presentation skills

Planning and organizational skills

Oral and written communication skills

Ability to collaborate with multidisciplinary teams

Fluency in written and spoken English

Problem solving skills

Proficiency with Microsoft Office Suite

Education

Master’s degree in pharmacy, nursing, or healthcare

Job description

Regional Pharmacovigilance Senior Manager page is loaded

Regional Pharmacovigilance Senior Manager

Apply locations United States - Remote time type Full time posted on Posted Yesterday job requisition id REQ-2922

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

The Regional Pharmacovigilance Senior Managerwill serve as a scientific expert and pharmacovigilance resource to external and internal partners within the region. The Senior Manager will also assess current processes to ensure adherence to applicable regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with argenx standards. This position will report directly to the Head of Regional Pharmacovigilance and EU/UK QPPV.

Roles and Responsibilities:

• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Lead in the harmonization of processes across the regions

• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Lead in the management of innovation projects for increasing Regional Team efficiency

• Support the Regional PV Lead in the establishment and maintenance of the applicable pharmacovigilance system specific to the country/region

• Support the Regional PV Lead in the revision of documents pertinent to Regional PV tasks

• Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region

• Contribute to the Pharmacovigilance System Master File (PSMF) data collection in the country/region

• Contribute to increase the visibility of the GPS team/function throughout argenx with focus on the region

• Closely collaborate with other functions including regulatory, marketing, medical, communications, quality, legal, as well as other teams as needed

• Develop relationships with cross functional teams as it relates to adverse event reporting and other pharmacovigilance activities

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

• Actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the Quality team

• 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 country/region

• Drive Continuous Improvement initiatives as needed

• May perform other tasks as appropriate

Skills and Competencies:

• Good presentation skills with the ability to communicate complex issues clearly

• Good planning and organizational skills with ability to manage competing priorities

• Good oral and written communication skills

• 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

• Relevant computer skills, including proficiency with Microsoft Office Suite

• Fluency in written and spoken English

Education, Experience and Qualifications:

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

• At least 7-11 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 5 years in pharmacovigilance/drug safety

• Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents

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

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At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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About Us

argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility.

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