Senior Manager, Pharmacovigilance (Deputy QPPV) job in

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Senior Pharmacovigilance Manager (Deputy QPPV)

Location: Bucharest, Romania

ICON is currently looking for a Sr. Pharmacovigilance Manager to join our Strategic Regulatory Services team within ICON. Working within our Strategic Regulatory Services team, you will work with a team of professionals who provide support to our clients including management of Safety and aggregate reports, risk management plans in compliance with our regulations and SOP’s. There is also an element of business development activities.

Combining the industry’s oldest and most experienced Clinical Outcome Assessments (COA) consultancies (Mapi & Oxford Outcomes), within ICON Commercialisation and Outcomes, and with access to more combined COA experience than all other CROs and consultancies, we can offer fantastic career opportunities. We provide a dynamic, stimulating and rewarding working environment for ambitious and passionate individuals looking to join a global, world-class consultancy business.

Responsibilities:

In the role of Sr. Manager Pharmacovigilance, you will be responsible for:

QPPV qualifications to lead PV projects.
Project management- managing client projects, including managing client relationships and project budgets.
Review, quality control, and submissions of Individual Case Safety Reports (ICSR’s) to clients/ client partners and/or regulatory agencies.
Preparing ICSR files for 3^rd party review including adjudication and review by Drug Safety Monitoring Boards.
Conducting audits or gap analysis of client pharmacovigilance systems including regulatory agency inspections and client and internal audits.
Providing training in pharmacovigilance legislation, regulations and industry best practices to colleagues and clients.

To apply you will need:

B.Sc. or advanced degree in in Health Sciences or registered nurse or equivalent relevant experience and training.
Extensive experience working within a pharmacovigilance environment including knowledge of ICH, EEA Good Pharmacovigilance Practices (GVP), European legislation and regulatory guidance
Excellent project management skills are required, as is the ability to effectively manage multiple simultaneous projects.
Strong people skills, ability to manage people, time and resources while developing a supportive team environment
The ability to interact with clients, to adapt to their priorities, and while providing strategic direction is essential.
Strong command of the English language coupled with fluency in local language.

Next Steps:

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

*LI-SG2

ICON Plc is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

Application process

Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.

Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.

One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.

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Senior Manager, Pharmacovigilance (Deputy QPPV)

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