Join our companies in their quest to drive powerful, positive, change that endures.

Clinical Safety Officer

Doccla

Doccla

United Kingdom · Remote
Posted on Tuesday, July 9, 2024

A bit about us

We’re Doccla, the virtual ward company. We provide patients and clinicians with the transformative power of remote patient monitoring.

Our existing customers are Hospitals, Community Services, and NHS Commissioners that we partner with to deliver tech enabled virtual wards. With our technology, logistics, and support patients can be discharged from a hospital ward to a virtual one and recover in the comfort of their own homes. Patients love our care pathways and health services become more efficient; it’s a win-win.

We are a young company with big aims and a lot of momentum. In the summer of 2022 we raised $18M in an oversubscribed A round led by General Catalyst, a top tier global VC fund and have gone from strength to strength since: we’ve won a series of large multiyear NHS contracts, extended 100% of our existing client contracts.

This is your chance to join us at a key stage of our growth. Our ambition is to be a category leader for virtual healthcare. You will be joining a highly entrepreneurial team that combines technical, clinical, operational, and commercial colleagues.

We're solving real problems for patients and health systems. we’re looking for dedicated people with a passion for healthcare.

Job Overview

We are seeking a highly skilled and experienced Clinical Safety Officer to join our dynamic team.

The Clinical Safety Officer will play a pivotal role in our rapidly scaling health tech organisation, ensuring the safety and regulatory compliance of our cutting-edge health technology solutions. This role involves monitoring and evaluating the safety of our products, developing and implementing risk management plans, and ensuring adherence to regulatory requirements. The ideal candidate will possess a strong background in clinical safety, risk management, and regulatory affairs within the health tech industry. They will collaborate with cross-functional teams to uphold the highest safety standards, ensuring our innovative solutions improve patient outcomes while adhering to regulatory requirements.

Key Responsibilities:

  1. Clinical Safety Management:
    • Lead on clinical safety activities including compliance with NHS Digital DCB 0129/0160 standards under responsibility of the CMO/ Senior Medical Lead.
    • Develop, implement, and maintain clinical safety protocols and risk management plans.
    • Monitor and evaluate the safety performance of health tech products throughout their lifecycle.
    • Conduct safety assessments and risk analyses, ensuring compliance with relevant regulatory requirements.
    • Chair Clinical Safety meetings and represent clinical safety at Clinical Governance Meetings.
    • Manage organisational incident log and share learning with stakeholders.
    • Stay current with clinical safety standards and regulatory guidelines relevant to health technology.
  2. Regulatory Compliance:
    • Ensure all clinical safety activities comply with relevant regulations, including DCB, MDR, and other global standards.
    • Prepare and maintain clinical evaluation reports (CERs) and other required documentation for regulatory submissions.
    • Assist in the preparation of technical files and regulatory submissions for market approval.
    • Collaborate with regulatory affairs to address compliance-related issues or queries.
  3. Adverse Event Reporting:
    • Oversee the identification, documentation, and reporting of adverse events and incidents related to health tech products.
    • Conduct thorough investigations of safety-related incidents and develop corrective and preventive actions (CAPAs).
    • Ensure timely and accurate reporting of adverse events to regulatory authorities.
  4. Cross-Functional Collaboration:
    • Work closely with quality assurance, regulatory affairs, and clinical teams to ensure the safety and efficacy of health tech products.
    • Provide clinical safety input during the development and post-market surveillance of health technology solutions.
    • Participate in cross-functional meetings and project teams to provide safety expertise.
  5. Training and Education:
    • Develop and deliver training programs on clinical safety and regulatory compliance for internal teams.
    • Stay updated on emerging trends and changes in regulatory requirements related to clinical safety in health technology.
    • Mentor and guide junior team members on best practices in clinical safety and regulatory compliance.

Experience:

  • Advanced degree in a clinical field (e.g., MBBS, RN, Para, PharmD) required.
  • Certification in clinical safety.
  • Minimum of 3 years of experience working as a Clinical Safety Officer within the healthcare (ideally health tech) industry.
  • Strong understanding of health technology and its regulatory landscape.
  • In-depth knowledge of relevant regulations, including DCB, MDR, and other global standards.
  • Excellent analytical skills and ability to interpret complex safety data.
  • Strong written and verbal communication skills.
  • Ability to work independently and collaboratively in a dynamic, fast-paced environment.
  • Excellent communication and interpersonal skills, with the ability to effectively communicate complex clinical information to non-clinical stakeholders.
  • Desirable: Proficiency in G-Suite, Jira and Confluence and safety database systems.

Key Competencies:

  • Attention to detail and accuracy
  • Strong organisational and project management skills
  • Problem-solving and critical-thinking abilities
  • Effective communication and interpersonal skills
  • Ability to work under pressure and meet deadlines

Working Conditions:

  • Full-time (or close to full-time)
  • Office based in London with the possibility of remote work.
  • Occasional travel may be required for meetings, training, and conferences.

How we work

We empower everyone to take ownership and responsibility for the company and their role within it. We act ethically and think of helping patients and protecting their safety first.

Whatever your role is, to thrive at Doccla, a can-do and action oriented attitude is essential. As is being a clear and open communicator who is receptive to feedback.

Our team is hybrid with offices in London, Denmark, Germany & Stockholm. Most of the team lives in and around London and visits the office one to three times per week to enjoy in person meetings, free lunch with the team, and the general perks of a WeWork with a glorious barista. The extent of remote vs office working will depend on your role, as some roles have the flexibility to be fully remote.

We have an employee equity pool that you can be part of so that as the company continues to grow you’ll have a share in its success.

Some of our employee benefits include

🌴 25 days of annual leave and up to 8 bank holidays per year
📅 Option to buy or sell holidays back to Doccla
📈
Employee stock options
🍇 Fresh fruit and snacks at HQ
🍝 Daily lunch provided at HQ
📚 £500 Learning & Development budget per employee
🧘🏽 Monthly allowance to a well-being platform. Providing access to in-home massages to
healthy food deliveries
🩺 Private health insurance
🫄 4 months full pay* for birthing person
🧑🏽‍🍼 4 weeks full pay for non-birthing person
💸 4% Pension on full basic pay
🛡️ 4x basic pay for Life insurance
🚲 Cycle to work scheme
🐶
Pet friendly office
🧾 £200 remote working stipend


What do you get for all your hard work?

  • A competitive compensation package (base + options) with half year and annual performance reviews.
  • Work at one of the most patient focussed and client centric healthtech startups, backed by top VC firms, General Catalyst & Speedinvest.
  • Growth. We want you to keep growing. That means trying new things, leading others, challenging the status quo and owning your impact. Always with our complete support.

Diversity at Doccla

We embrace diversity at Doccla. To build a product that is valued we need a team with all kinds of different perspectives, experiences and backgrounds. That's why we're committed to hiring people from different backgrounds, race, religion, national origin, gender identity, sexual orientation, gender identity, age or disability.

We understand that applying for a new job takes a lot of work and we really value your time. We are really looking forward to reading your application!

Safer Recruitment

Doccla is committed to the principles of safer recruitment, ensuring that safeguarding and promoting the welfare of children and vulnerable adults is central to our recruitment processes.

A Disclosure and Barring Service (DBS) check will be required for all posts with access to children or vulnerable adults. Please note that it is an offence to apply, offer or accept to do any work with children (paid or unpaid) if disqualified from working with children.