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Pharmacovigilance Lead - UK

Employer
Simbec-Orion
Location
Homeworking, UK
Salary
Competitive
Start date
22 Sep 2021
Closing date
21 Oct 2021

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Discipline
Clinical Research, Pharmacovigilance
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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 your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives.

Summary of the Position:

We are looking for a Pharmacovigilance Lead to join our Pharmacovigilance department.

You will perform the role of Pharmacovigilance (PV) Project Lead and will act as the primary point of contact for external clients on a range of studies/projects. You will provide a high level of service to our clients by ensuring deliverables are executed to high standards on time and in line with the contractual agreement. You will perform PV tasks on other studies/projects and will be involved in training/mentoring PV team members. You will work with the Senior PV Manager or Head of Department to address any project concerns and will assist with audits/inspections. You will manage departmental functions and processes to ensure compliance with internal and external regulatory guidelines.

Key Accountabilities:
  • Act as the primary point of contact on the project(s) for clients.
  • Ensures that project-specific documents (i.e. Protocol, Investigator Brochure (IB), Safety Management Plan (SMP) etc) are compliant with internal SOP/Work Instructions (WI) and regulatory guidelines.
  • Ensures PV activities are in line with the SOW, budget and to initiate Change in Scope (CIS) process when required.
  • Responsible for all aspects of PV set-up for projects as per the contractual agreement (SOW and budget).
  • Ensures that projects are managed effectively and compliantly in line with SOP/WI and regulatory guidelines during maintenance/conduct phase.
  • Responsible for project finance by ensuring that the correct PV revenue for projects is recognised and forecasted.
  • Identifies process deviations or gaps and ensure that a CAPA/file note is generated and finalised in a timely manner.
  • Assists with generation and review of SOPs and WI.
  • Develop and mentor PV team members.
  • Attends project-specific and internal meetings and represent PV in external audits/inspections.

Minimum Requirements:

Essential:
  • BSc Life Sciences Degree
  • Demonstrable experience in Pharmacovigilance case processing, quality reviewing of ICSRs and database reconciliation
  • Previous experience in Pharmacovigilance Project Management
  • Previous experience in a Clinical Research Organisation
  • Demonstrated experience in all aspects of Developmental and Postmarketing Pharmacovigilance.

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

Job Profile - Pharmacovigilance Lead.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.

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