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JOB DESCRIPTION

• The role of Nominated Signatory Associate provides support to the Nominated Signatory, including the (pre)-approval of specified materials and activities linked to promotion, interactions with Health Care Professional and Organisations and other related areas such as non- promotional health education
• As the GDPR Data Protection Officer (DPO), you will be an integral part of the team at the company, helping achieve compliance with GDPR and any other relevant data protection law and privacy legislation. As the main point of contact on GDPR compliance within the BeLux, you will advise on any internal and external data protection and privacy queries and oversee the company’s broader data protection

KEY ACCOUNTABILITIES

Mdeon VISA Approval from A to Z

• Acts as single point of contact and provides administrative support related to NS activities
• Fully handles the Mdeon process (preparation, compliance-related controls, timely submission and FU resubmission of amended file in case of refusal)
• Handles the requests from abroad MCs in compliance with the specific Belgian procedures and deadlines (sends approval from BeLux NS team, approves fees intended by other MCs or global)

Grants and chairs

• Ensures planning, coordination, review of project proposal, controlling, execution, follow-up and correct closure of all grants and chairs (annual report request, payments and follow-up, closure of remaining accruals, closing of file in database);
• Obtains all approvals in the routing system (within medical and finance Depts);
• Handles budget provisions (monthly file to Genpact), ensures accurate budget allocation (payment % split) and liaises with Business Finance for KAP follow-up;
• Prepares the contracts, ensures they are signed and updates the contract database;
• Contacts KEES and hospitals on the contracts and projects. 

Sponsoring /meetings approvals

• (Pre-)approves promotional activities (GEIP) against predefined principles on attendees, costs, material, location, meeting status, contracts, motivation letter...) and requests additional information if required;

Promotional material

• Review each material into the system and attribute a NS ID
• Checks the final approved field materials

Contribution Committee

• Prepares the committee by collecting all project requests and controls the mandatory documentation (budget breakdown, project ..);
• Prepares the presentation, writes the minutes of the meeting, ensures all FU actions with committee members or requestors and keeps track of all projects in xls overview;

Monitoring

• Samples, Expired material and Regulatory reconciliation (Smpc, Pil, abridged version)

Disclosure

• Support for the implementation of the sunshine act. Ensure all reportable transfers of values to HCP, HCOs and Patient Organisations are identified and properly uploaded on the be platform in due time. Relationship with customers (informative communication) and global support team.

Be local key contact person for data protection, including:

• Information incidents: support investigation involving personal data in your country, report incident to local authority and coordinate notification to data subjects (if applicable)
• Action and manage Subject Access Request (SARs) management for
• Manage business queries relating to privacy, triage to Global Privacy Officer (if necessary)

Assure a local framework/ resource is in place to:

• Stay up to date with any changes to regulatory/legislative data protection to continuously ensure GDPR
• Inform, advise, and support the company and employees how to be GDPR compliant and how to comply with other data protection laws
• Set up effective local DP assurance process including privacy risk identification and assessment, SOPs, controls, training, monitoring etc.
• Support Global Privacy Officer with the roll-out of policies/ procedures, guidelines, trainings and provide oversight for its appropriate implementation
• Meticulously maintain incident and breach logs and take necessary follow-up actions

EDUCATION, QUALIFICATION, AND EXPERIENCE

Essential

• Bachelor degree
• Experience in pharmaceutical and/or medical device industry in medical/ scientific or clinical development departments
• A solid understanding of the deontological code and practices and their application to health care professionals
• Adequate understanding of privacy legislation
• Good understanding of business, commercialization, and marketing
• Good understanding of local organisation/ processes/ systems/ procedures and guidelines
• Ability to work in cross-functional teams providing medical expertise and clinical support for the commercial organization
• Strong communication skills
• Good knowledge of French, Dutch and English
• Translation skills to mother tongue
• Excellent computer skills: Word, Excel (pivot tables),PowerPoint, outlook, internet, SAP

Desirable

• Previous experience in administrative position within large companies is appreciated
• Expert knowledge of GDPR and its implementation

The Nominated Signatory Team 

A team of two people, responsible for:

2. All communications to healthcare professionals regarding scientific information and publicity of company’s medicines in BeLux
3. Ensuring a quality system guaranteeing the proper delivery of samples medical procedures and sending yearly to the competent authorities (FAMHP) the list of samples
4. Guaranteeing that all stakeholders within the company in compliance matters are well trained and follow local pharmaceutical legislation and code of conduct of pharmaceutical

Check the conformity to the Belgian and Luxembourg pharmaceutical legislation of these company activities:

1. All meetings organised by the company (including advisory boards, grouped meetings, scientific events, Mdeon, ...) and service fees granted to the Consultants (both HCP and non-HCP consultants)
2. All sponsorships and donations
3. All promotional materials
4. All changes in the scientific notices of the Regulatory Affairs department
5. Preparation, verification, and submission to the Belgian and Luxembourg authorities of all transfers of values from the company to Health Care Professional, Health Care Organisations and Patient Organisations

We use these computer systems in our daily job:

Veeva CRM for approving the meetings, Veeva Vault Promomats for approving promotional materials, NS portal and Mdeon website

As DPO you are supported by the local compliance officer and legal council and you collaborate closely with the global data privacy team.