Quality Associate with a passion for documentation, HCP compliance and PV
Would you like to play a key role in one of my clients' BENELUX affiliate? Do you find it exiting to cooperate with colleagues both internally as across functional areas? Are you looking for a job where you can get responsibility and personal impact in an energetic team that puts the patient first? Then, this is the job for you!
You will be part of the Scientific Affairs department reporting to the Quality and PV manager. You will be working closely together with internal and external stakeholders to ensure processes and systems are maintained and in line with regulatory expectations and industry best practice.
In overview your primary responsibilities will be:
- Pharmacovigilance: - Reporting, reconciliation and follow up of Adverse Events/Other Experience cases for all products in the BeNeLux - managing central shared mailboxes
- Document management: - document distribution (approval/ read and understood) - maintain the quality documents matrix for the Benelux employees - collaborate with the local people managers to ensure employees get trained in the correct documents - reach out to global departments to ensure the department stays compliant with globally initiated documents - provide input on improvements to local SOP's and update accordingly or coordinate the update with the local document owners
- HCP/HCO Compliance: - you will be responsible HCP compliance person for HCP/HCO Activity Notification Forms BNL - you will perform a monthly internal disclosure upload as well as the yearly disclosure for BNL in terms of transfer of value
- Scientific affairs department: - general administrative support for the scientific department. - ensure payments to HCP/HCO's - follow up on contracts/payments grants following medical events - back up for intake of customer complaints - administrative support for clinical studies f.e. internal/external communications, maintenance of databases, financial administration - provide support for internal as well as external audits - act a SME for the area's you are working in
- Budget: - follow up on department specific budget
You will work mainly with local colleagues but also across the global organization and be in contact with numerous people in multiple departments and functions. As part of this, you can also expect approximately 10 travel days per year to meet colleagues and partners.
About the department
You will be part of a department of 8 colleagues with lots of different area's of interest to work in. They are the quality point of contact to the BENELUX employees.
The goal is to provide best-in-class expertise, facilitate knowledge sharing and develop pragmatic solutions for potential compliance deficiencies and/or improvements in order to ensure the BENELUX affiliate to be compliant to all local and global regulations.
You will join a small team of dedicated and energetic people in an informal work environment where everyone is heard and proactivity is highly appreciated.
Our aspirations are to excel at executing, being professional and ambitious, while never forgetting to have fun!
You have preferably a graduate in pharmacy, engineering or chemistry with thorough knowledge in several pharmaceutical disciplines - clinical trials, pharmacovigilance and/or pre-clinical studies - and quality regulations, or equivalent a broad knowledge of all areas combined with deep expert knowledge in one pharmaceutical discipline and quality regulation. Or you have already several years of experience in the specific job related areas.
Microsoft office 365 should not have any secrets for you, excellent excel skills are beneficial.
If you have a combination of product and/or audit experience, it will naturally benefit your application.
You are a "self-starting" and highly structured person and you are able to plan your own work and get things done on time. Working both with local people as well as cross-organizational takes strong communication and collaboration skills - in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions.
Excellent written and oral communication skills (Dutch, English and French (optional)) and good archiving habits. Ability to define risk as it relates to specific non-conformances or trends and work with colleagues to mitigate identified risks.
What are you getting in return?
By joining our team you will have a unique opportunity for personal and professional development and to contribute to business critical processes.
By joining this company you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people's lives around the world and at the same time create profitable growth.
We offer you a full time contract of indefinite time, 32 days of holidays, meal vouchers, a hospitalization plan and pension scheme, a mobile phone, laptop and discount on your private internet connection