Pharmacovigilance Manager

3 weeks ago


London, United Kingdom EPM Scientific Full time

POSITION DETAILS

Title: Pharmacovigilance Manager

Upward Reporting: Head of Quality and Drug Safety

Position Type: Permanent, ongoing with a 6-month probation period

Location: Egham, UK

Hours: Regular working hours are Monday to Friday from 9.00am to 5.30pm, with two days office attendance and three days remote working.

Travel: Some international travel may be required


ABOUT THE COMPANY

A global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.


DESCRIPTION OF THE ROLE

  • Responsible for all processes and operating procedures to ensure compliance with appropriate regulations and quality standards
  • Work with the Head of Quality and Drug Safety and the EU QPPV to identify gaps with current processes, handle management escalation, as well as identifying possible resolutions
  • Develop & manage Standard Operating Procedures
  • Oversee case management and case handling, including providing back-up support for case handling staff where needed
  • Oversee safety database management
  • Oversee signal detection and risk management
  • Review and approve Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experience Reports (PADERs)
  • Review and manage updates to Risk Management Plans, including liaising with clinical colleagues on post-marketing activities worldwide
  • PSMF maintenance & update
  • Internal training of staff where necessary
  • Establish key performance metrics to measure compliance and data quality
  • Preparation with relevant teams for any internal audits or regulatory inspections
  • Serve as the pharmacovigilance subject matter expert for internal audits and regulatory inspections
  • Responsible for management of external pharmacovigilance service providers (i.e., national responsible/representatives)
  • Develop Safety Data Exchange Agreements with Contract Organisations


ESSENTIAL REQUIREMENTS FOR ROLE

  • Bachelor’s degree or equivalent experience in science; Masters or PhD in pharmacy, biological science or related field
  • Experienced professional with a strong background in pharmacovigilance who is passionate about safety in drug development/post-marketing
  • Proven track record in pharmacovigilance; extensive experience in CRO or pharmaceutical industry
  • Excellent communication skills, both written and verbal
  • Project management skills
  • Independence and the ability to lead a team effectively
  • Observational and analytical skills
  • Good time management and the ability to work to tight deadlines
  • Ability to problem solve and make decisions quickly


WHAT’S ON OFFER:

  • A competitive salary with benefits.
  • The chance to contribute and be part of a team whose work directly benefits healthcare and strives to improve people’s lives.
  • A real hands-on opportunity to gain a high degree of commercial exposure.
  • The chance to work alongside world-leading scientific experts.
  • Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery.



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