ABOUT US

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.

THE ROLE

We are looking for a Pharmacovigilance Manager to join our Pharmacovigilance team where you will manage the day-to-day operations within the Pharmacovigilance (PV) department by liaising with the PV team and the Head of Pharmacovigilance to ensure the effective functioning of the department. You will identify any gaps in Simbec-Orion’s Standard Operating Procedures (SOPs) and provide the necessary corrective actions. You will maintain an oversight of projects and ensure compliance of all PV deliverables.

KEY ACCOUNTABILITIES

• Responsible for monitoring and management of departmental documents, quality, workload and resource allocation.
• Ensure timely escalation of issues and concerns to the Head of Pharmacovigilance.
• Provide support to the Head of Pharmacovigilance and assist with review of proposals, costings for PV business and bid defense meetings.
• Work collaboratively with internal and external stakeholders to ensure the PV aspects of projects are managed in line with budget, scope of work and within agreed timelines to meet clients expectations.
• Perform departmental revenue comparison against PV team members timesheet to ensure logged time is consistent with the total professional fees for the department and the revenue is in line with PV activities performed.
• Represent the PV department during internal meetings and external client or regulatory authority audit/inspections.
• Generate and review departmental SOPs and WI and perform gap analysis.
• Identifies new training and development opportunities for the PV department.

SKILLS REQUIRED

Essential

• BSc Life Sciences Degree or equivalent
• Previous experience in a Clinical Research Organisation (CRO)
• Demonstrable experience in all aspects of PV activities i.e. case processing, aggregate reporting, regulatory reporting etc.
• Knowledge of PV regulatory guidelines
• Previous experience in PV Project Management

Desirable

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

WHY YOU SHOULD JOIN US

Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.

We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you. our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.