Pharmacovigilance Manager

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.