Senior Pharmacovigilance Specialist

Posted 14 September 2022
LocationTring
Job type Permanent
DisciplineMedical & Drug Safety
Reference67005
Contact NameValerie Kalna

Job description

Senior Specialist Pharmacovigilance

An opportunity has arisen for an experienced drug safety professional to join global leading contract research organization providing services to the pharmaceutical industry as Senior PV Specialist.

The role is permanent, full-time and hybrid in either Buckinghamshire or Hertfordshire office, however, offers significant WFH flexibility.

You will be responsible for

  • Managing safety information from various sources (spontaneous, literature, clinical studies, med info etc.)

  • Case processing including data entry and data entry quality check

  • Literature screening

  • Support with creation of ICSRs of adverse drug reactions from various

    sources and reporting of ICSRs to the relevant authorities

  • Assist in preparing PSURs, DSURs, RMPs and signal detection reports

  • Creating and reviewing SOPs and work instructions

  • Assisting during audits and inspections

  • CAPA management and tracking CAPA status

  • Collecting relevant data for PSMF

    You will bring

  • Life Science degree

  • 3+ years of experience in Pharmacovigilance

  • In-depth knowledge of drug safety regulations, industry practices and

    standards

  • Great team player as well as independent contributor

  • Excellent written and verbal communication skills

  • English fluency

  • Agile and pro-active attitude, resilient in challenging situations

    If you don’t want to miss out on this opportunity, please get in touch ASAP.

    Email: Valerie.kalna@biotalent.com Phone: 0203 892 8777