POSITION DETAILS Title: Pharmacovigilance Manager
Upward Reporting: Head of Quality and Drug Safety
Position Type: Permanent, ongoing with a 6-month probation period
Hours: Regular working hours are Monday to Friday from 9.30pm, with two days office attendance and three days remote working.
Travel: Some international travel may be required
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.
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
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 manage updates to Risk Management Plans, including liaising with clinical colleagues on post-marketing activities worldwide
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., Develop Safety Data Exchange Agreements with Contract Organisations
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
Project management skills
Good time management and the ability to work to tight deadlines
A competitive salary with benefits.
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.