Job details

Vigilance Project Manager

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At VCLS, we are seeking an experienced and highly organized individual to join our Vigilance team as a Vigilance Project Manager. In this role, you will be responsible for leading and managing cross-functional projects related to pharmacovigilance and drug safety. You will collaborate with internal and external stakeholders to ensure project success and compliance with regulatory requirements.

Responsibilities:

Lead and manage vigilance projects, including signal detection, risk management, and safety reporting
Develop and maintain project plans, timelines, and budgets
Coordinate and collaborate with cross-functional teams to ensure project objectives are met
Prepare and deliver project updates and reports to stakeholders
Ensure compliance with regulatory requirements and guidelines
Identify and mitigate project risks and issues
Manage internal and external resources to optimize project efficiency
Contribute to process improvement initiatives within the Vigilance team

• Bachelor’s degree or equivalent experience.

• Minimum of 4 year direct project management experience at a Contract Research Organization (CRO) or pharmaceutical company and/ or 6 years of pharmacovigilance experience.

• Knowledge of global and local Vigilance regulations and legislation, both pre- and post-marketing, drugs and medical devices preferred.

• Strong project management, interpersonal, verbal and written communication skills, both internally and towards clients.

• Ability to identity, document, track and resolve project action items for multiple programs simultaneously.

• Ability to create, review and revise documentation, processes and procedures as they relate to PV activities, to identify issues/problem areas, assess compliance, and communicates findings to the appropriate team(s) and management.

• Experience with industry standard safety database(s)

• Project financial expertise including invoicing, revenue recognition, margin analysis, scope management and resource management.

• Demonstrated supervisory skills preferred.

• Demonstrated independent problem solving and issue resolution track record.

• Excellent interpersonal and client management skills.

• Effective presentation skills.

• Must be flexible and adaptable to quickly changing project priorities.

• Must be able to speak fluent English.

• Ability to travel to VCLS locations, clients, and professional/scientific meetings.

Average salary estimate

$100000 / YEARLY (est.)

min

max

$80000K

$120000K

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What You Should Know About Vigilance Project Manager, VCLS

At VCLS, we're on the lookout for a dynamic and detail-oriented Vigilance Project Manager to lead our pharmacovigilance initiatives. This is a crucial role where your expertise will shine as you manage projects related to drug safety, signal detection, and risk management. You'll be working closely with internal teams and external stakeholders, ensuring that every project not only meets its objectives but also complies with stringent regulatory frameworks. Your day-to-day will involve developing project plans, timelines, and budgets, as well as preparing comprehensive updates and reports for stakeholders. We're looking for someone with at least four years of project management experience, ideally in a Contract Research Organization (CRO) or pharmaceutical company, along with a solid background in pharmacovigilance. You'll need to bring your strong communication and interpersonal skills to the table, allowing you to navigate complex project dynamics and collaborate effectively. Additionally, your ability to identify and solve problems, track project actions, and adapt to changing priorities will be key to your success in this role. If you're ready to join a forward-thinking team that values innovation and compliance in drug safety, then the Vigilance Project Manager position at VCLS might just be the perfect fit for you!

Frequently Asked Questions (FAQs) for Vigilance Project Manager Role at VCLS

What are the main responsibilities of a Vigilance Project Manager at VCLS?

As a Vigilance Project Manager at VCLS, your core responsibilities will encompass leading and managing a variety of pharmacovigilance projects. You'll be involved in signal detection, risk management, and safety reporting while collaborating with cross-functional teams to meet regulatory requirements. Additionally, you will prepare project updates and ensure compliance with all relevant guidelines.