Achieva Group Ltd

Associate Business Process Leader, PV

Location
Hertfordshire
Salary
£600 - £650 per day
Posted
14 Apr 2021
Closes
14 May 2021
Ref
BH-25605
Contact
Sophie Fosh
Hours
Full Time
Contract Type
Contract
Experience Level
Senior Management
Our global pharmaceutical client has a vacancy for an Associated Business Process Leader (Pharmacovigilance).
 
Our client is looking for candidates based in the UK.
 
This is an initial 12-month full time contract.
 
Job Purpose:
The ultimate purpose of this role is to ensure and facilitate PV affiliate process execution in respect to the implementation of the Clinical Trial Regulation (CTRi) through representation of the Business Process Leaders in the respective project teams.
The Associate Business Process Leader - CTRi will be a part of relevant workstreams (ICSR process, ICSR systems, Reference Safety Information Process, CT related workstreams) and lead the affiliate safety working group involved for consultation on the processes.
The person will be responsible to receive and aggregate the relevant information from the workstreams, assess, share and consult on the various processes.
Further, the individual will be responsible to attend the scheduled project and affiliate working group meetings, to bring expertise about the regulation implementation to the working groups and the various stakeholders.
 
Education/Qualifications
 
Minimum:
Bachelor’s Degree in healthcare profession, pharmacy or relevant life science or nature science discipline
 
Strongly desired: Further qualification/certification in project management methodologies and/or change management.



Experience, Skills, Knowledge:
 
•          7 or more years’ clinical research, development, pharmacovigilance or related experience
•          5 or more years’ experience in the pharmaceutical/biotechnology industry is strongly preferred.
•          2 or more years of affiliate regulatory or safety as well as head quarter Pharmacovigilance is preferred.
•          Detailed knowledge of the PV and CT regulations applicable in the EEA is essential as well as  PV, GVP, ICH-GCP and other relevant standards and guidelines 
•          Set-up of Global Clinical Trials in various geographies in the EEA
•          Knowledgeable of UK Exit situation for Pharmacovigilance and MHRA expectations
•          Good knowledge of the drug development process
•          Good project and process management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such.