Operations Scientist

Operations Scientist

Location: High Wycombe

Working mode: Hybrid, 3 days per week on-site and 2 WFH

Duration: 12 months initially

Hours: Full-time hours, 37 hours per week

Hourly rate: Competitive hourly rate (PAYE and Umbrella pay type options available)

The Operations Scientist will demonstrate pharmacovigilance expertise, overseeing daily operations and management of  the Central Case Intake team’s activities, including US due diligence and compliant processing of adverse events within  the Global Safety System, ensuring adherence to safety regulations and corporate policies.  

This role will act as a point of contact and subject matter expert for Central Case Intake, providing external vendor support  and operational oversight and management on a daily basis, collaborating with business partners, JJIM organizations,  including Product Quality Vigilance, US Commercial and regional local safety offices and applies critical thinking to  optimize processes and efficiency.  

The Operations Scientist will also perform and provide end-to-end oversight of Individual Case Safety Report (ICSR)  processing for assigned products. This role ensures timely, accurate, and compliant case processing, supporting vendor  management, quality assurance and continuous improvement. 

The Operations Scientist will serve as the primary liaison for audits and inspections, participating in interviews and  responding to information requests and will lead CAPA (Corrective and Preventive Action) activities including root cause  analysis, corrective action tracking, and verification of effectiveness.

roles and responsibilities

Performance 

• Lead strategies for Central Case Intake, US due diligence, and complaint management ensuring  adherence to global standards, procedures, and regulatory requirements. 

• Provide strategic input and foster collaborative relationships with multiple functional groups  including but not limited to Global Medical Safety, US Commercial, Product Quality Vigilance, PV  Systems and Quality organizations to improve processes, and maintain compliance. 

Operational Excellence & Process Optimization 

• Oversee case management activities, including intake, literature surveillance, due diligence and  business partner reconciliations, ensuring consistency, integrity, and compliance. 

• Identify, and/or participate in multidisciplinary projects to improve efficiency, accuracy, and  compliance, leveraging best practices and technological systems (e.g., LSMV, EZ Reporter and  SafetyVerse).  

• Continuously evaluate the effectiveness of case processes, address gaps, and communicate  findings and proposals to ensure they meet evolving standards and organizational goals.

Regulatory Compliance & Risk Management 

• Perform investigations to proactively identify compliance risks, root causes, and opportunities for  mitigation. 

• Support regulatory inspections, health authority audits, and system reviews, ensuring readiness  and compliance. 

• Perform the investigation of compliance issues, coordinate corrective and preventative actions  (CAPAs), and support the development of robust compliance frameworks. 

• Ensure timely completion of complaint handling activities, aligned with regulatory and procedural  standards. 

Key Performance & Metrics Management 

• Monitor and determine/implement improvements to vendor performance metrics and KPIs,  ensuring alignment with organizational objectives. 

• Continue to evaluate organizational practices, policies, and procedures for adherence to quality  standards and continuous improvement.

Development 

• Mentor team contributors responsible for audits, inspections, CAPAs, vendor oversight, safety  updates, and legal inputs. 

• Foster and demonstrate a high-performance culture within the team.

how to succeed

Required Minimum Education: Other: 

• RN/RPh PharmD or Health/Biomedical degree (BS/PhD), or LPN with Bachelor’s degree or equivalent pharma experience 

Required Years of Related Experience:  

• Minimum of 5 years pharma experience

Required Knowledge, Skills and Abilities:  

• Previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including individual  and aggregate reports.  

• Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety  reporting/regulations.  

• Experience in high volume work environment  

• Ability to mentor and coordinate resources  

• Ability to coordinate and harmonize workflow activities of the team  

• Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy  and compliance  

• Ability to utilize appropriate initiative and autonomy in achieving objectives; works independently

• Ability to facilitate change  

• Demonstrate strong Credo values  

• Ability to organize training activities and train personnel on pharma safety topics  

• Ability to identify training needs of team members  

• Excellent verbal, written and presentation skills  

• Excellent computer skills (MS Office suite) and familiarity with safety systems including SME hands-on with LSMV, EZ  Reporter, SafetyVerse

benefits

This role offers a very competitive hourly rate. This contract will initially run for 12 months.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.