Pharmacovigilance (PVG) Project Leader

Bionical Emas; East Midlands; Remote; GBP 50,000 - 70,000; Full time

Job summary

A global clinical supply organization is looking for a PVG Project Leader to ensure delivery of effective pharmacovigilance support for client projects. This remote role requires a Bachelor's degree and prior pharmacovigilance experience. The ideal candidate should possess strong knowledge of EU GVP legislation and post-marketing PV regulations. This position offers 25 days of vacation, health insurance, and a flexible work environment.

Benefits

25 days of vacation

Vacation days purchasing scheme

Discretionary Annual Bonus

Sabbatical of 3 to 6 months after 2 years

Free food and beverages

Life Insurance

Health Insurance and Employee Assistance Programme

Flexible and hybrid work

Qualifications

• Previous pharmacovigilance experience in PV project management or an equivalent role.
• Strong knowledge of EU GVP legislation and guidance.
• Experience of post marketing PV regulations.

Responsibilities

• Lead the establishment of client specific pharmacovigilance systems.
• Provide strategic advice on pharmacovigilance requirements to clients.
• Represent PV in client meetings as the primary liaison.
• Oversee project activities contributing to delivery and invoicing accuracy.
• Prepare, coordinate and review regulatory PV documents.
• Monitor evolving PV regulations ensuring compliance.

Skills

IT Experience

Robot Programming

PMBOK

HVAC

Project Leadership

Conflict Management

Meeting Facilitation

Schedule Management

Project Management

Project Management Software

Microsoft Project

Leadership Experience

Education

Bachelor's degree in a relevant field

Job description

A Career with Purpose

Bionical Emas is a global Early Access Programs (EAP) and Clinical Trial Supply (CTS) group bringing life-changing medicines to patients around the world. Their range of services and capabilities benefit many of the world's leading pharma and biotech companies.

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 would love to hear from you.

About the Role

We are looking for a PVG Project Leader to set up and ensure delivery of effective pharmacovigilance (PV) support for client projects. This is a remote role reporting to the EVP Medical Affairs.

What will your job look like

• Lead the establishment of client‑specific pharmacovigilance systems including safety management plans and data management plans
• Provide strategic advice on pharmacovigilance requirements to clients
• Represent PV in client meetings and act as the primary liaison for ongoing projects.
• Oversee project activities contributing to delivery and invoicing accuracy
• Maintain and review SOPs, working instructions and PV working tools such as safety databases and forms
• Prepare, coordinate and review regulatory PV documents (DSUR, PSUR, PBRER, EU‑RMP, PSMF, SDEA)
• Monitor evolving PV regulations ensuring ongoing compliance and awareness.
• Contribute to client and company quality systems including audits and CAPA / QE management
• Support SAE case management including regulatory assessment and submissions to authorities
• Collaborate with clinical scientific and regulatory colleagues to provide integrated services

What will you need to succeed

• Bachelor's degree in a relevant field
• Previous pharmacovigilance experience in PV project management or an equivalent role
• Strong knowledge of EU GVP legislation and guidance
• Experience of post‑marketing PV regulations

What will you get in return

We want you to do your best work! We care about our peoples’ 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 2 years of service)
• 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

Does this sound like you?

It is time to apply and we cant wait to hear from you!

Even if you dont meet 100% of the requirements be confident in yourself and dont hesitate to apply!

PLEASE NOTE : We will be longlisting applications as soon as we receive them so please apply early to register your interest.

We Are Bionical Emas

We are proud of our people and proud of our achievements. We encourage and hire people with diverse backgrounds voices beliefs and perspectives into our growing global workforce. We do not discriminate on the basis of actual or perceived race color creed religion national origin ancestry citizenship status age sex or gender (including pregnancy childbirth and pregnancy‑related conditions) gender identity or expression (including transgender status) sexual orientation marital status military service and veteran status physical or mental disability genetic information or any other characteristic protected by applicable federal state or local laws and ordinances. Bionical Emas management team is dedicated to this policy with respect to recruitment hiring placement promotion transfer training compensation benefits employee activities access to facilities and programs and general treatment during employment.

Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Bionical Emas and need accommodation or special assistance please let us know by sending an email with your request to the recruitment team at .

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

Key Skills

IT Experience, Robot Programming, PMBOK, HVAC, Project Leadership, Conflict Management, Meeting Facilitation, Schedule Management, Project Management, Project Management Software, Microsoft Project, Leadership Experience

Employment Type : Full Time

Experience : years

Vacancy : 1