Senior Pvg Project Leader - Derby, United Kingdom - Bionical Emas

Bionical Emas

Verified Company

Derby, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

A Career with Purpose
Bionical Emas is a global Clinical Research Organization (CRO) bringing life-changing medicines to patients around the world.

We combine Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) to deliver a unique, seamless service to our pharma and biotech clients.

At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people.

Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success.

If you are inspired by changing the lives of patients all over the world, we'd love to hear from you.

About the Role

As a Senior Pharmacovigilance Project Leader, you will be pivotal in supporting a single client during the set-up of an EU and US post-marketing pharmacovigilance system ready for product launch and providing excellent customer service to our clients.

If you want to be part of our company's vision of bringing life-changing medicines to patients around the world and this position sounds exciting, keep reading

What will your job look like?

Perform the role of the Project Lead for postmarketed pharmacovigilance projects as assigned, as per client contract and applicable Standard Operating Procedures (SOPs)/Work Instructions (WIs)
Provide advice on pharmacovigilance strategy and requirements for marketed products to clients
Participate in client meetings and liaise with clients regarding ongoing projects
Assist with establishing clients' postmarketing pharmacovigilance systems, including preparation and/or review of SOPs and pharmacovigilance management plan
Preparation, coordination, and review of key pharmacovigilancerelated regulatory documents for marketed products, including the Periodic Safety Update Report (PSUR), Periodic Adverse Drug Experience Report (PADER), Periodic Benefit Risk Evaluation Report (PBRER), European Union
Risk Management Plan (EU-RMP), Pharmacovigilance System Master File (PSMF), Safety Data Exchange Agreement (SDEA)
Coordination and execution of ongoing activities such as literature review, signal detection, project steering committee meetings, liaison with QPPV and local QPPVs, management of labeling documents, interaction with regulatory authorities
When required, manage and support pharmacovigilance case management activities, including case processing, regulatory assessment of ICSRs, and submission to relevant regulatory authorities and third parties
Maintain awareness of regulations and changes to regulations concerning pharmacovigilance
Participation in client/potential client audits and regulatory authority inspections as required

What will you need to succeed?

Pharmacovigilance experience in case management, PVG project management, or equivalent
Extensive postmarketing pharmacovigilance experience
Understanding of EU GVP legislation and guidance
Understanding of Clinical Trial Regulations and guidance
Experience managing projects
Strong communication skills
Strong organizational skills

What will you get in return?

We want you to do your best work We care about our people's well-being, their personal development and providing a true work-life balance.

Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.

25 days of vacation
Vacation days purchasing scheme
1 extra vacation day per each 3 years of service
Discretionary Annual Bonus
Sabbatical of 3 to 6 months (after 3 years of service)
1 volunteer day per year
Free food and beverages at all offices
Life Insurance
Health Insurance and Employee Assistance Programme
Employee Support Networks help us continue to build on our inclusive culture
Flexible and hybrid work
Training and Personal Development Program

Does this sound like you?

It is time to apply, and we can't wait to hear from you_

Even if you don't meet 100% of the requirements, be confident in yourself and don't hesitate to apply

We Are Bionical Emas

We Are Bionical Emas, where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together, we make a difference by powering an inclusive future for all. Be you, with us.

**Powering the patient journey