Pharmacovigilance Operations Specialist

5 days ago


Bracknell, Bracknell Forest, United Kingdom Lifelancer Full time

**Job Title:** Pharmacovigilance Operations Specialist

**Job Overview:

We are seeking a highly skilled Pharmacovigilance Operations Specialist to join our team at Lifelancer. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the effective delivery of business objectives, including compliance with adverse event case processing, reporting timelines, and data quality.

**Responsibilities:

  • Deliver 100% compliance with respect to adverse event/reaction reporting timelines.
  • Ensure ICSR processing is compliant with company procedures, including internal and regulatory timelines.
  • Request follow-up information in accordance with company procedures and timelines, utilizing the Product Quick Guide and query reports where appropriate.
  • Maintain key areas of responsibility within the local PV system, ensuring compliance with company procedures, legislation, and regulation.
  • Develop strong cross-functional relationships and assist business partners in navigating and complying with PV relevant procedures.
  • Provide accurate PV relevant advice by promoting and implementing current policies and guidance on PV Training, IIS, and any other relevant projects.

**Requirements:

  • A basic knowledge of European and International Pharmacovigilance regulations and laws.
  • A thorough knowledge and understanding of the regulatory requirements in the UK, Ireland, and Malta.
  • A thorough knowledge and understanding of ICH-GCP requirements.
  • A minimum of 2 years experience or equivalent within the Pharmacovigilance environment.
  • Demonstrating a solid working knowledge of PV systems and processes and wider business functions.
  • Excellent presentation/communication skills.
  • A Life Science degree or equivalent.

**Salary:** £55,000 - £65,000 per annum (dependent on experience).

**Benefits:** Competitive salary and benefits package, including pension scheme, life insurance, and opportunities for professional development and growth.

**Location:** Bracknell, UK.



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