Simbec Orion Group Ltd

Senior Pharmacovigilance Executive

Slough, United Kingdom
22 Feb 2021
24 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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.

Main Duties and Responsibilities:

We are looking for a Senior Pharmacovigilance Executive to join our Pharmacovigilance department.

Ensures quality in Individual Case Safety Report (ICSR) processing and timely submission of Expedited Safety Reports (ESRs) to the regulatory authorities. Develops 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. Carries out PV tasks on other studies/projects and is involved in mentoring PV Executives. Works with the 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.

Minimum Requirements:

  • 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.

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

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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