Vacancy Senior Regulatory Affairs & Pharmacovigilance Specialist – Amsterdam
For a global market leader at the forefront of research to deliver innovative health solutions we currently have an exciting opportunity for a Senior Regulatory Affairs & Pharmacovigilance Specialist.
As a Senior Regulatory Affairs (RA) and Pharmacovigilance (PV) Specialist you will be responsible for meeting all RA requirements for obtaining and maintaining local product registration and overseeing activities for the entire product portfolio as applicable. You will collaborate with colleagues to ensure compliance with local laws and regulations which may include but are not limited to: review submission packages, translate and review product information, provide input for local PV and RA agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements streamline and improve processes, training, communication of safety issues. Besides this, you are responsible for planning of departmental activities and monitoring KPI’s. You will report directly to the PV and RA Country Lead.
Main responsibilities but not limited to;
- Develop local product registration plans and keep oversight of the local ongoing maintenance activities
- Plan and Lead submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorised products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorisations in accordance with local regulations and global standards
- Maintain and optimise the departments infrastructure to ensure compliance to Global Pharmacovigilance and Regulatory Affairs procedures and country regulations
- Responsible for execution of local PV and RA processes and activities in alignment with PV and RA systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation
- Provides support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable
- Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues
- Supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations
- Supports training of the local company staff, distributors, vendors, business partners including training documentation
- Backing up colleagues and adjusting time schedule in such that there is no cap in adverse event reporting
- Health, life science, or medical science degree or equivalent by education
- Minimum of 5 years of industry experience in Pharmacovigilance and Regulatory Affairs
- Experience with interacting with the local Health Authorities
- Must have a general knowledge of local registration regulations within the Netherlands and be an expert in RA processes/activities
- Knowledgeable of Pharmacovigilance regulations and activities
- Excellent communication skills and the ability to influence decision making
- Good time management skills
- Fluent in English and Dutch (written and spoken)
You will be joining a global dynamic and challenging environment with great opportunities for personal development.
- Competitive salary and a 3% year-end bonus (Salary range from 65 – 80K)
- 35,5 days of leave;
- Attractive collective health care insurance package with considerable reduction rates;
- Solid Pension Plan;
- AIP Plan;
- Travel allowance;
- Numerous training, coaching and e-learning modules for long term job opportunities and development
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Principal Consultant | Biotech & Pharma