Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.

Summary of the Position:

We are looking for a Senior Pharmacovigilance Executive to join our Pharmacovigilance department. You will be based remotely in the UK.

You will ensure quality in Individual Case Safety Report (ICSR) processing and timely submission of Expedited Safety Reports (ESRs) to the regulatory authorities. You will develop into the role of PV Project Lead on a range of studies/projects and ensure deliverables are maintained to high standards and in line with the contractual agreement. You will carry out PV tasks on other studies/projects and will be involved in mentoring PV Executives. You will work with the Senior PV Manager and Head of PV to address any project concerns and assist the management team during audits and Standard Operating Procedure (SOP)/Work Instructions (WI) generation.

Key Accountabilities:

• Perform ICSR processing and specifically Quality Check of ICSRs from all sources and ensure high quality of case data.
• Prepare and perform submission of ESRs to regulatory authorities as per the regulatory timelines via EudraVigilance or other channels.
• Act as a PV Project Lead on post-box/partial service PV projects and ensure high-quality project deliverables and compliance.
• Liaise with clients and other internal departments to address any concerns/issues and work diligently until resolution.
• Support the PV Lead in pharmacovigilance activities.
• Identify process deviations and prepare CAPA files in a timely manner.
• Support with a client or regulatory authority audits/inspections.
• Assists with generation and review of SOPs and WIs.
• Train and mentor new employees, as required.
• Attend project and internal meetings.

Minimum Requirements:

Essential:

• BSc Life Sciences Degree or equivalent.
• Demonstrated experience in developmental and/or post-marketing pharmacovigilance.
• Previous experience with ICSR processing, QC, and compliance.
• Previous experience with ESR submission QC and compliance.
• Previous experience in a Clinical Research Organisation (CRO).
• Previous experience in pharmacovigilance Project Management of small studies.

Desirable:

• MSc Life Sciences or equivalent.
• PhD in Life Sciences or equivalent.
• Pharmacy degree or equivalent.
• Experience in Business Development activities.

Job Profile - Senior Pharmacovigilance Executive.pdf




Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.