Senior Scientist - Patient Safety

Senior Scientist - Patient Safety

Cheshire (WFH Initially)

6 Month Contract

Brief

Senior Scientist - Patient Safety needed for a highly reputable Pharmaceutical organisation based in Cheshire who are looking to employ an experienced and well-rounded Senior Scientist - Patient Safety that takes pride in their work with a thorough understanding of all aspects of pharmacovigilance, good knowledge of regulatory and drug development processes and possesses the ability to support audits/inspections and CAPA development.

What the role entails:

Some of the main duties of the Senior Scientist - Patient Safety will include:

• Drive a culture of continuous improvement, high performance, flexibility and quality emphasising a "can do" attitude and innovative approaches, across the company's Pharmacovigilance (PV) system.
• Identify opportunities to improve and simplify processes and guidance, provide practical solutions and drive implementation.
• Utilise knowledge of pharmacovigilance and associated regulatory and drug development processes to maintain and support the global inspection readiness strategy.
• Participate in and/or support activities for GVP, GCP and GMP audits/inspections both globally and with local affiliates.
• Working across CMO, identify issues and risks and propose options to mitigate them.
• Working across CMO, support RCA and CAPA development and monitor completion.
• Provide training to CMO and other functional groups in key areas of expertise.
• Provide support to outsourcing partner(s) to facilitate compliance with regulatory and legal requirements and maintain inspection readiness.
• Contribute to communication and change management activities associated with CMO initiatives.
• Manage relationships/partnerships/alliances external to the CMO function that are essential to delivering the company's pharmacovigilance License to Operate responsibilities, e.g. with the company's affiliates.
• Working collaboratively, provide expertise and sharing best practices across all regions and in all partnerships.
• Monitor, interpret and validate current, new and changing legislation and manage the impact of changes.
• Use deep understanding of pharmacovigilance processes and regulations provide compliance support to safety and regulatory teams and submissions.
• Serve as the delegate, where appropriate, for the IR Leads.
• Ensure that appropriate, up-to-date records are maintained for compliance.

What experience you need to be the successful Senior Scientist - Patient Safety:

Essential:

• A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
• Proven ability to work cross-functionally, across cultures and time zones in a virtual/remote environment
• Leadership skills, including experience of leading project teams
• Thorough scientific knowledge sufficient to understand all aspects pharmacovigilance issues
• Thorough knowledge of the drug development process
• Problem solving and negotiations skills
• Good attention to detail
• Excellent written and verbal communication skills

Desirable:

• MSc/PhD in scientific discipline
• Knowledge of new and developing pharmacovigilance requirements/expectations
• Knowledge of existing company external alliances and collaborative projects
• Experience of working with third party suppliers
• Experience of working in a global organisation, preferably within the pharmaceuticals industry
• Knowledge of QMS and continuous improvement methodologies
• Ability to lead change without authority
• Comfortable working with data and facts/figures

This really is a fantastic opportunity for a Senior Scientist - Patient Safety to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!

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