Manager Affiliate Operations
CLS Services (Nederland)
For one of our clients we are looking for a Manager Affiliate Operations.
This position serves as the first point for the day-to-day interactions with and guidance of the companies PV Affiliate Drug Safety Officers (DSOs) to ensure Affiliate local PV systems, processes and procedures are compliant and efficient and in line with global/regional regulatory requirements and Astellas policies and procedures.
This role is under supervision of the Affiliate Operations Group Lead.
Acts as first point of contact for local DSOs to provide operational support:
- Responsible for implementation of quality management for the global PV AFM function and the assigned PV Affiliates.
- Ensure oversight over compliance-relevant aspects (e.g., but not limited to, ICSR handling, training requirements, CAPAs, implementation and updates of procedures at the local PV Affiliate level, etc.)
- Provides support for implementation of up-to-date legislation.
- Ensure oversight of inbound and outbound ICSR compliance for the assigned Affiliates, including root cause analysis for late cases.
- Liaise with PV AFM and PV QMS function for process improvements resulting from compliance failures.
- Responsible for coordination of PV affiliates periodic self-assessment to ensure global and regional consistency, completeness, and accuracy in PV Quality aspects and procedures at an affiliate level.
- Responsible for audit & inspection readiness activities for PV AFM and/or assigned PV Affiliates.
- Support PV AFM during PV audits and inspections.
- Support the development of CAPAs from initiation to completion (global/regional/local Affiliate) related to issues and/or performs root cause analysis for identified issues.
- Perform trend analysis, where applicable, on identified issues and propose targeted actions.
Who we're looking for
We are looking for a candidate with a degree in Health Science, Life Science, Medical Science. You have at least 5 years of experience within PV, as a DSO or equivalent. You have an in-depth understanding of all aspects of PV and related disciplines and a strong industry perspective.
- Compliance mentality and good understanding of good documentation practices;
- Excellent communication (English) and influencing skills to deal with cultural sensitivities and to influence and motivate others;
- Service orientated and pro-active problem-solving attitude;
- Good organizational skills, logical in thought and detail focused.
Our client is a multinational pharmaceutical company, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Contract for at least one year. |
Days of leave: 38
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.