Senior Pharmacovigilance Executive

Job title:

Senior Pharmacovigilance Executive

Company

Lifelancer

Job description

Job Title: Senior Pharmacovigilance ExecutiveJob Location: Great Britain, United KingdomJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: AssociateAbout UsOur passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine.We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.The RoleWe are looking for a Senior Pharmacovigilance Executive to join our Pharmacovigilance team where 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.

EssentialSKILLS REQUIRED

• 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.

WHY YOU SHOULD JOIN USSimbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to 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 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.Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

Expected salary

Location

London

Job date

Sun, 16 Feb 2025 23:05:15 GMT

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