|Location: Cheshire East||Salary: £450 - £500 per day|
|Sector: Pharmaceuticals, Client Delivery, Medical Communications, Medical Devices, Life Sciences||Type: Contract|
|Contact: Zak Mendoza||Job Published: 27 days ago|
Senior Scientist - Patient Safety
Cheshire (WFH Initially)
6 Month Contract
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:
- 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
- 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!
Services advertised by Gold Group are those of an Agency and/or an Employment Business.