Drug Safety Submissions Specialist

Drug Safety Submissions Specialist

Location: High Wycombe

Work mode: Hybrid, 3 days on-site, 2 WFH

Duration: 12 months (opportunity for contract extension)

Hours: 37 hours per week

Pay rate range: Competitive hourly rate (This role is outside IR35)

roles and responsibilities

• Takes the lead and acts as SME on key initiatives and functional activities.

• Clinical Trial Reporting Support.

• Acts a delegate to more senior staff in the team upon request.

• Performs duties as per the rota such as daily /weekly checks and report reviews.

• Plays a key role in team meetings and daily liaison with team members to identify and resolve processing issues.

• Review ICSRs within Safety Reporting scope of responsibility for reportability based on Standard Operating Procedures (SOPs), Work Instructions and internal guidance documents.

• Triaging and prioritization of ICSRs for regulatory reporting by following the business rules and SOPs.

• Perform review submissions review and no submit review.

• Responsible for daily manual or E2B submission of ICSRs to Health Authorities and Business Partners.

• Record, track and monitor successful transmission in OST.

• Produce CIOMS / MedWatch and fax/email, distribute, and upload to document storage.

• Handles delegations (interactions with Local Safety Officers (LSOs) who delegate regulatory reporting to GMSO)

• Provide guidance and support to clarify procedures (e.g., training) to ensure compliance relating to SR collaboration with business partners, European Medicines Agency (EMA), Regulatory Authorities (RAs), Local Safety Officers (LSOs), Pharmacovigilance (PV) nominated person and other groups such as Global Clinical Operations (GCO), licensing partners and Regulatory Affairs (RA).

• Identifies and develops solutions for areas needing improvement and considers the use of technology for the automation of process steps.

• Take a leading role in providing input and supporting authoring consistent processes that meet both internal and regulatory standards to meet global requirements.

• Identifies and actions any gaps or inaccuracies in controlled documents relevant for performing safety reporting activities, business continuity and audit/inspection readiness.

• Liaise with other functions for resolution of queries and issues.

• Identifies and resolves issues or prepares documentation and options for solution where escalation is required. 

• Prepares agendas, facilitates team meetings and takes minutes.

how to succeed

• Must have experience with ICSR reporting to EMA/MHRA and preference is for experience with Distribution Rule management.

• Distribution and reporting experience is ideal.

• Previous automation experience is desirable.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

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. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

questions

If you would like some additional information about the role please contact:  sara.marsalo@randstadsourceright.co.uk

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”.