EU Pharmacovigilance Lead / Deputy QPPV

We are currently looking for a EU Pharmacovigilance Lead / Deputy QPPV who will s upport the EU QPPV to ensure EU pharmacovigilance deliverables including systems and processes are implemented and maintained in compliance with regulatory requirements.

Key Accountabilities/Responsibilities:

The position will have the following key responsibilities:

• Serve as the back-up for the EU QPPV in her/his absence
• Function as the contact point for Pharmacovigilance System Master File (PSMF) update
• Lead, coordinate and maintain the ongoing PSMF updated management activities
• Establish, facilitate, and maintain regular interactions with Local EU-QPPVs, program teams and other cross functional groups with regard to compliance related to data and processes that involve Global Patient Safety (GPS)
• Work closely with GPS management contributing to the prioritization, planning, and implementation of strategic EU projects
• Identify and communicate internally EU potential operational or functional pharmacovigilance deviations and ensure that contingency or mitigation plans are implemented in order to assure successful completion
• Support the preparation of GPS documents and processes (including SOPS, work instructions, PSMF, RMP, PSUR, pharmacovigilance agreements or signal detection)
• Support GPS inspections and internal audits
• Collaborate with GPS leadership on the development of processes related to pharmacovigilance operations, systems, and other activities
• Maintain working knowledge of GPS contractual documents, work closely with GPS management to monitor status, coordinate and communicate updates as applicable
• Assist with preparing and coordinating responses to DSMB or other external requests from EU-Regulations as needed
• Maintain knowledge of EU and global regulatory requirements as applicable to drug safety and pharmacovigilance
  
  

Desired Skills and Experience:

• Excellent planning and organizational skills
• Excellent oral and written communication skills.
• Demonstrated ability to collaborate with multidisciplinary teams and manage multiple projects simultaneously
• Solution oriented with ability to work independently
• Ability to clearly communicate complex issues
• Relevant computer skills, including proficiency with MS Office and EudraVigilance environment
• Fluency in written and spoken English. Other EU languages are a plus but not required
• Bachelor’s degree in related scientific field (MD, PhD or Master’s degree a plus)
• At least 3 years of experience in the pharmaceutical/biotech industry with at least 2 years in pharmacovigilance/drug safety
• Knowledge of the maintenance of the PSMF and developing standard operating procedures (SOP).
• Knowledge of EU-pharmacovigilance regulatory requirements
• Experience in attending EU-PV inspections
• Experience as Local QPPV for any EU country, fulfilling local regulation is a plus
• Experience with regulatory submissions and medical writing is preferred

Offer:

• A competitive salary package with benefits;
• A work environment in a human-sized, dynamic, rapidly growing biotech company