This is how you will make the difference
As Benelux Safety Lead you will be responsible for the end-to-end setup, operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidance and global business requirements. You will be a key strategic partner for the local business and provide consult and collaboration to all affiliate stakeholders and global functions to support local, regional and global objectives. Additionally you will contribute to the Global and Regional PV strategy as required.
Does this look appealing to you? Please continue reading below.
In this role you will be:
- Accountable for establishing and maintaining a local/regional PV structure and related practices in compliance with local Regulation and in synergy with the organisation’s Global PV system.
- Acting as the local/regional expert in all matters pertaining to PV within the post-marketing space and the aligned territory and providing strategic and operational consult to the local business. Contributing to PV matters in the Clinical space as required in collaboration with other GSRS functions.
- Responsible for establishing optimum and harmonised processes for the receipt, collection and submission (as applicable) of Individual Case Safety Reports (ICSRs) for Company products from any source. Ensuring procedures related to Literature Screening and ICSR Follow-up are in place.
- Maintaining awareness of all Organised Data Collection Programs (ODCPs) (such as Patient Support Programs (PSPs) and Market Research Programs (MRPs), Early Access Programs (EAPs), Compassionate Use (CU), Registries, Digital and Social Media Activities that are relevant to the local territory; ensuring appropriate PV Processes are in place (e.g. Adverse Event Collection); ensuring adherence with the Global PV Governance structure and procedures.
- Authoring and maintaining PV-related training and ensuring regular delivery to all Affiliate staff, PV Operations Vendors and Service Providers including but not limited to training pertaining to AE collection responsibilities.
- Responsible for the identification of outsourcing needs and the recruitment, onboarding, training, oversight and general end-to-end set-up of PV Operations Vendors, Service Providers and other third parties; ensuring alignment with applicable global oversight strategies for vendors.
- Leading and collaborating with local Finance and Global Management on budget and resource planning for local PV activities.
- Authoring local documents, such as Standard Operating Procedures (SOPs), Guidelines, Safety Management Plans/Manuals, Vendor Service Agreements, and ensuring content alignment with GSRS procedures and Local PV requirements; ensuring regular updates of these documents as per the established review cycles and as required according to enhancement needs.
- Maintaining a constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure. Supporting and hosting Post-Marketing inspections to ensure the successful close-out.
- Contributing to the global strategy for PV oversight and compliance management; implementing effective measures to monitor compliance and quality of key local PV procedures and operations (including but not limited to ICSR collection and Health Authority (HA) submissions, as applicable) in the post-marketing space in collaboration with International PV (IPV); incorporating the use of empirical data (both quantitative and qualitative) to drive continuous improvement of the local PV system.
- Acting as the primary contact and Subject Matter Expert (SME) for local Audits and as required for local HA Inspections (including the interviewee role and collating responses to document requests); playing a lead role in the facilitation and coordination of local audits and inspections in collaboration with the applicable Quality teams; ensuring there is timely and appropriate communication throughout the life-cycle of the Audit or Inspection to key Local and Global stakeholders including International PV (IPV); contributing as required to the Global Auditing strategy as it relates to the local territory.
- Contributing to the GSRS PV Regulatory Intelligence infrastructure by maintaining a detailed understanding and continuous awareness of the local PV Regulations and any updates or changes; actively participating in relevant local trade associations, working groups and creating appropriate connections with local Health Authorities and influential institutions within the PV space.
- Participating in any public consultations on planned changes to PV Regulation in close collaboration with International PV (IPV). Anticipating changes in PV Regulations and planning for changes in local procedure and templates accordingly.
- As required, contributing to projects related to any technical updates to PV practices (e.g. electronic submission of ICSRs to HAs).
- Fostering an environment of sharing best practices, learnings and innovations with the wider PV and Regulatory affiliate network.
- Responsible for appropriate communication with local Health Authorities in partnership with other local functions (e.g. Regulatory Affairs and Medical Affairs); collaborating with regulatory colleagues to ensure safety notifications and submission of safety documents are performed in a compliant manner; coordinating with GSRS management to address safety related requests from the local HA.
- Maintaining close working connections with all local teams and functions; the primary point of contact to be consulted for all matters that impact PV within the affiliate; a standing member of relevant affiliate governance structures (as needed) to be kept up to date on local plans and projects that may have an impact on PV; providing strategic and operational recommendations to affiliate teams and projects to facilitate compliance with PV requirements.
- Responsible for the fulfilment of local contact for Pharmacovigilance (LCPPV) Responsibilities as per local regulation; This LCPPV ensures there is comprehensive understanding of these specific responsibilities at the Local, Regional and Global level, in order to enable compliance with regulatory expectations for the role.
- Managing other local safety staff and resources as is applicable.
- Contributing to and/or leading additional Local, Regional or Global strategic priorities, projects and responsibilities as required.
- Completing relevant training on the organisation’s PV system on-time before commencement of local QPPV responsibilities. Maintaining a high level of knowledge and understanding on the organisation’s local and global PV systems.
What you bring
As the ideal candidate you recognise yourself in the following profile:
- At minimum you have a Bachelor’s degree in medicine, pharmacy or life sciences
- 7+ years in drug safety/pharmacovigilance in a pharmaceutical industry setting
- Well versed in interacting with third parties (e.g. PV operations vendors)
- Great knowledge of Good PV Practices
- Direct experience in GxP compliant quality systems
- Experience with Adverse Events Intake systems
- Experience in writing procedures, training materials and effectively delivering training to a diverse audience
- Experience (e.g. interviewee, control room, document request) of Audits and Regulatory Inspections
- Strong command of the English and Dutch language
- You are a resident in the Netherlands
- In-depth knowledge of Global, Regional and local PV regulations and requirements.
- Well-developed technical writing skills with the ability to produce clear, concise documentation and communications. Good presentation and analytical skills.
- Excellent Project Management skills.
- Good proficiency with common software such as Microsoft Word, Excel, PowerPoint, Outlook.
- The ability to work effectively/collaboratively in a fast-paced matrix environment.
- Effective managerial skills, self-starting, the ability to adapt – to work independently or as part of a team, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritise.
- The display of strong decision-making skills
- Lastly; the ability demonstrate innovative thinking.
What's in it for you
To reward you for your efforts in executing this role to the utmost best of your abilities and helping the organisation attain its goals, the following will be offered:
- A competitive base salary
- An additional bonus at an interesting percentage
- A company car / car allowance
- A solid pension plan
- Thirty vacation days