Pharmacovigilance Scientist

Pharmacovigilance Scientist

Ellipses Pharma is a global clinical-stage drug development company focused on progressing first- or best-in-class oncology drugs. Ellipses’ maturing clinical pipeline is progressing three clinical phase-2 programmes with an additional programme due to commence Phase 1 studies in 2026.

Ellipses Pharma is supported by a global Scientific Advisory Group comprising over 300 leading Oncology Key Opinion Leaders to de-risk initial asset selection and provide critical insights into clinical trial design.

The Role

The Pharmacovigilance Scientist contributes to the oversight of all safety aspects of Ellipses oncology clinical trials. They will assist in the ongoing review of data in all our studies, helping to ensure robust data and identify trends in safety, proactively mitigating risk, and ensuring compliance with global regulatory requirements to protect patient safety.

The role will report to the Associate Medical Director and work closely with the Clinical Scientists and Clinical Operations team.

Key Responsibilities

· Represent the patients’ interests ensuring their safety at all times in Ellipses clinical trials

· Work closely with the Associate Medical Director regarding review of safety data

· Analyse data listings (safety and clinical) for accuracy and trends and report findings

· Review literature for emerging safety signals and ensure relevant internal stakeholders are informed

· Support the Associate Medical Director in the review of AEs, SAEs and SUSARs as required

· Works in close partnership with Ellipses pharmacovigilance and vendor medical monitors

· Support the preparation and review of regulatory documents, e.g. DSUR, Investigator’s Brochure

· Review safety data and clinical packages to inform the drafting & presentation of clinical data at internal meetings. Support the Associate Medical Director at external safety review meetings

· Provide oversight of CRO/PV and other vendors, ensuring activities are conducted in accordance with applicable study-level Safety Management Plans, SOPs and regulatory requirements, in alignment with the CRO/PV partner

· Work with Clinical Development, QA and external partners to ensure accurate and timely safety data flow and issue resolution

· Maintain inspection-ready safety documentation and support any audits or internal quality review

· Identify safety compliance risks; support assessment and management of CAPA activities related to safety operations

Skill and Experiences

· Bachelor’s degree in Life Sciences (Master’s or PhD preferred) in Pharmacology, Biology, Pharmacy, or related field

· 3+ years of experience in pharmacovigilance, drug safety, or clinical research within a biotech, CRO or pharmaceutical industry

· Oncology therapeutic experience advantageous

· Demonstrated ability to think laterally when reviewing safety data and understand the impact of side effects on protocols

· Understanding of local and global drug safety regulations/guidelines and processes and clinical trial oversight, including global GCPs and adverse event management

· Experienced in providing input into key regulatory documentation

· Experience in pharmacovigilance or drug safety or clinical research

· Knowledge of global safety regulations (ICH, GVP, FDA guidelines) and familiarity with safety reporting processes

Personal Attributes.

· Strong ethical judgment and commitment to patient safety

· Strong attention to detail with an ability to spot inconsistencies in case data and be able to meet strict reporting timelines

· Analytical and critical thinking with an ability to identify patterns in adverse events

· Regulatory awareness and compliance mindset

· Organisation and time management in order to work to deadline driven safety requirements

· Clear documentation and communication skills to write clear case narratives and summarise safety data

· Self starter, being comfortable to work independently but with the ability to collaborate, both internally and externally

· Adaptability to be able to work in a rapidly growing biotech environment

· Integrity and accountability with an ethical mindset and ability to escalate concerns when required

Ellipses Pharma is an organisation that values the strength of collaboration, inclusive and quick decision making, knowledge sharing and a culture built on working together on site. As a small but growing company face to face interaction is highly valued.

We recognise that a more hybrid approach is at times required and we do support some element of remote working where operationally appropriate to help employees with work life integration.

By balancing in-person presence with occasional remote working, we ensure we remain agile while protecting the unique benefits that come from working side by side.

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