Clinical Safety Officer

ABOUT POSITIVE SOLUTIONS LIMITED:

Positive Solutions has been delivering healthcare technology to pharmacies across the UK since 1993 and has more recently expanded into care homes. Headquartered in Chorley, Lancashire, the company provides a suite of interoperable applications that streamline pharmacy and care home operations, improve patient engagement, and deliver business intelligence insights. Its solutions serve everyone from single-site independents to corporate groups and national pharmacy estates, helping them automate workflows, save time and improve the patient experience.

ABOUT TAG SOFTWARE GROUP:

TAG Software Group is a team of experienced investors and operators dedicated to acquiring, enhancing, and growing mission-critical software companies serving SMB, enterprise, and public sector customers.

Founded as part of a permanent home for software companies, we don’t buy to sell. Our focus is on long-term partnerships that protect your legacy, employees, and customers.

Our in-house team delivers an efficient, transparent, and seller-friendly process, ensuring speed and certainty of close. Once part of TAG, your company gains access to proven best practices, dedicated value-creation resources, and the extended ecosystem of our sister companies, including proprietary in-house technology including and — helping your business reach the next level.

KEY RESPONSIBILITIES:

* Act as the named Clinical Safety Officer for an agreed portfolio of products, covering both live services and new developments, and keep the scope of that responsibility clear.
* Produce and maintain clinical risk management plans, hazard logs, clinical safety case reports and supporting evidence in line with DCB0129, reviewing them when products, workflows, integrations or operating conditions change.
* Speak directly with pharmacy customers when needed to understand their workflows and safety concerns.
* Bring pharmacists, other clinicians and technical teams together to identify hazards, assess clinical risks, agree controls and verify that they work as intended.
* Work with Product and development teams during discovery, refinement and sprints to agree clinical and safety requirements, acceptance criteria and controls.
* Assess the clinical safety impact of proposed features, changes and releases early enough to influence design and testing.
* Advise on whether products and releases are clinically safe and ready to go live, stating unresolved risks clearly and escalating concerns where the evidence does not support release.
* Lead clinical safety input to NHS accreditation and assurance activity, including clinical witness testing and governance discussions, and be able to explain and defend the safety case.
* Provide supplier evidence and support to customers carrying out their own deployment responsibilities under DCB0160.
* Investigate reported clinical safety incidents and potential hazards, determine their impact on the safety case, and make sure learning informs controls, documentation and future product decisions.
* Communicate clinical risks clearly to both technical and non-technical audiences, and challenge decisions where the supporting evidence is insufficient.
* Improve clinical safety processes across the full product lifecycle so that responsibilities, reviews and decisions are consistent and timely.

Requirements

* Minimum of one year’s experience in a Clinical Safety Officer role.
* Successful completion of NHS Digital Clinical Safety training.
* Current registration as a clinician with a relevant professional regulatory body.
* Hands-on experience working in a community pharmacy, with a sound understanding of dispensing workflows and the confidence to discuss them directly with customers.
* Proven experience applying DCB0129, including personally producing and maintaining hazard logs and clinical safety case reports.
* Experience working closely with software development teams, taking part in sprints and agreeing clinical and safety requirements with Product and developers.
* Strong ability to lead hazard assessment, judge the quality of evidence, and clearly communicate residual risk to stakeholders.
* Comfortable asking difficult questions, making proportionate decisions under pressure, and challenging a release or control where clinical risk has not been adequately addressed.
* Willingness to travel to our Chorley office as required.

PREFERRED:

* Experience of NHS digital assurance, EPS, PMRs, medicines data or clinical witness testing.
* Experience getting to grips with complex existing systems and their workflows, alongside newer products and integrations.
* Experience working within a modern software or technology company.

Benefits

* Work from home: A remote-first role with the flexibility to manage your day in a way that works for you.

* Competitive pay: A salary that reflects your skills and your growth with us.
* Varied and engaging work: Work across both established systems and new product. developments, giving you exposure to a broad range of clinical workflows and challenges
* Close collaboration: Work alongside the teams who design, build and test our products, so you can influence safety from the earliest stages of development.

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