Hamlyn Williams has partnered with an innovative biopharmaceutical company that is in a big phase of growth due to the success of its pipeline.
Due to this growth, the company is currently looking for a PV Operations Director at a senior level to support individual case safety report (ICSR) handling from post-marketing. The position is closely working with the global PV operations team (US, Japan) and global case processing vendors and act as primary contact.
The role involves but is not limited to:
• Contributes to the global PV Operations strategy and decision making via the global PV operations team.
• Responsible for overseeing the ICSR collection system for processing, reconciliation and reporting.
• Manages and provides trainings on ICSR activities, safety procedures and processes on a regular basis.
• Oversees and works with clinical study teams, develops and maintains study-specific SAE Flow Plans/Safety Management Plans.
• Leads, manages and mentors staff and assigns responsibilities as appropriate to maximize the team outputs and provides opportunities for individual growth. The position is a line management role so will need to be office based but there is flexible working as well.
This is a great opportunity for someone specialising in Pharmacovigilance Operations who is looking for their next challenge. Any questions please don't hesitate to get in touch.