PVG Project Leader

09 Nov 2021

​Bionical Emas - the Company

​Bionical Emas is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, delivering a unique, seamless approach to bring life-changing medicines to patients around the world.

​With clients, staff and offices around the globe, we offer a varied and international experience.

Our clients range from smaller biotech’s to large global pharmaceutical companies, all with different needs and expectations.  As a business, we have invested heavily in ensuring we have the systems, processes, and people, to deliver for the very varied requirements of our clients. The culture of Bionical Emas is friendly, flexible and supportive, where all staff are encouraged to grow, develop and exceed their expectations.

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Main Responsibilities

• Perform the role of QPPV for certain projects as agreed with the Chief Medical Officer

• Provide advice on pharmacovigilance strategy and requirements for investigational and marketed products to pharmaceutical and biotechnology clients

• Lead/participate in specific projects as directed by the Head of Pharmacovigilance

• Participate in client meetings and liaise with clients regarding ongoing projects

• Assist with establishing clients’ pharmacovigilance systems including preparation and/or review of SOPs, safety management plans and pharmacovigilance data management plan

• Assist with maintenance of Bionical Emas pharmacovigilance systems including preparation and/or review of SOPs, working instructions and other working tools such as forms and spread sheets and safety databases

• Preparation, coordination and review of key pharmacovigilance related regulatory documents for both investigational and marketed products, including (but not limited to); DSUR, PSUR, PBRER, EU-RMP, PSMF, SDEA

• ​Co-ordination and execution of on-going activities such as literature review, signal detection, project steering committee meetings, liaison with QPPV and local QPPVs, management of labelling documents, interaction with regulatory authorities

• Oversight of project activities and provide input into invoicing for specified projects

• Ensure compliance with EU regulatory requirements including contribution to client and/or Bionical Emas quality systems

• Provide input into clinical, scientific, regulatory and other services provided by Bionical Emas

• Maintain awareness of regulations and changes to regulations concerning pharmacovigilance

• Ensure that the department personnel are adequately trained on Bionical Emas Procedures and applicable pharmacovigilance legislation/guidance

• Assist with business development activities including proposals and bid defence meetings as required

• CAPA management of department and project related CAPAs

• Any other reasonable task as approved by the Head of Pharmacovigilance

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Key things we are looking for

• Degree in medicine, pharmacy, biological science or related subject

• Post-graduate qualification in pharmacovigilance

• Extensive experience in all aspects of pharmacovigilance including pre- and post-marketing

• Management experience

• Expertise in GVP guidance and working knowledge of US PVG legislation

• Aligned with Company Objectives and enthused to set a positive example, promoting the department where possible

• Ability to act as an Mentor

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​Make a difference

​At Bionical Emas, we are committed to supporting our clients and our staff, so that they can bring life-changing medicines to patients around the world. Join Bionical Emas on our mission to make a difference. 

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