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 We are looking for a PVG Project Leader to provide effective pharmacovigilance consultancy and support for client projects and oversee the development and management of key client accounts.
You will work cross functionally with the Clin Dev & EAP team to deliver operation excellence whilst keeping patient centricity at the core of everything you do.
What will your job look like?
Pharmacovigilance Project Leadership : Act as the Project Lead for pharmacovigilance projects, providing strategic advice to clients and managing specific projects as assigned Client Interaction and System Management : Lead client meetings, maintain pharmacovigilance systems, and oversee the preparation and review of SOPs, safety management plans, and data management tools Regulatory Documentation : Prepare, coordinate, and review essential pharmacovigilance regulatory documents for both investigational and marketed products, such as DSUR, PSUR, PBRER, EU-RMP, PSMF, and SDEA Ongoing Project Activities : Manage ongoing activities like literature reviews, signal detection, project steering committees, liaison with QPPVs, and regulatory authority interactions Compliance and Quality Assurance : Ensure compliance with regulatory requirements, contribute to client and Bionical Emas quality systems, and support audits and inspections Team Mentoring and Workload Management : Mentor Project Leaders and Case Processing Team members, liaise with senior management regarding workloads, and resource needs Pharmacovigilance Case Management : Manage and support case management activities, including SAE entry, regulatory assessments, and submissions to relevant authorities Cross-Departmental Contributions : Provide input into clinical, scientific, and regulatory services, maintain awareness of regulatory changes, and inform relevant departments of significant updates Project and Document Management : Prepare and maintain project-specific procedural documents, ensure proper training for team members, and manage project documentation and CAPA Financial and Administrative Tasks : Assist in the preparation of fee invoices, approve project-related expenses, and manage the hours and expenses of contracted team members What will you need to succeed?
A Bachelor's degree in pharmacy, biological science or similar Pharmacovigilance experience in PVG project management or equivalent Proficient understanding of EU GVP legislation and guidance Proficient understanding of Clinical Trial Regulations and guidance Experience managing a variety of PVG projects Some case processing management background would be advantageous Experience across a wide range of phase from I-IV would be useful 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 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 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!
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.
Protecting your privacy and the security of your data is a longstanding top priority for us.
Please consult our Privacy Notice to know more about how we collect, use, and transfer the personal data of our candidates.
Our Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over Bionical Emas' use of your personal information.
By applying for the above position, you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates: Privacy Policy - Bionical Emas applicable to your place of residence.
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