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Pharmacovigilance and Regulatory Affairs Lead Belgium & Luxembourg

Apply here

Aline Vandermeeren
Business Unit Manager


Apply here

Aline Vandermeeren
Business Unit Manager



Aline Vandermeeren
Business Unit Manager
+32 497 71 58 10


Introduction

Do you like to:

  • Work in an exciting culture, based on respect for people, striving for excellence and high integrity
  • Work in an environment based on collaboration and team spirit
  • Be part of a continuous innovating company
  • Invest in your personal development
  • Have a high level of autonomy in your daily activities
  • Have a flexible working environment (e.g. homeworking policy)
  • Profit from a pharma competitive salary & benefit package

Job description

PEOPLE MANAGEMENT

  • Coach, share learnings and be back-up within the medical shared services team (4-5 people)
  • Discuss issues and strengths within the team and handle issues/problems as appropriate
  • Track and inquire on process quality deviations
  • Participate to planning and budgeting for the department
  • Actively participate in recruitment, diversity, and retention and hiring efforts
  • Identify improvements for efficiency and participate in task forces


PHARMACOVIGILANCE/COMPLAINTS/DEVICES

  • Supervise Adverse Events (AE) and Product Complaint (PC) management and ensure AE/PC are processed on time and according to company standards (LQS) and regulations
  • Function as the national nominated contact person for pharmacovigilance according to Law 25 March 1964 and Royal Decree 14 Dec 2006 as modified respectively by law 3 august 2012 and RD 28 May 2013 and as described in circular 600
  • Understand the roles and responsibilities of the EU Qualified person (QPPV) and act as the official contact person with the EU QPPV. Being in constant/easy access and communication with the EU QPPV and helping in the population of the global PSMF
  • Act as a single contact point for the Competent Authority on a 24h basis


INFORMATION and PUBLICITY

  • Be (or become) the RIP (= Responsible for Information and Publicity)
  • Participate to policy redaction, governance and training of stakeholders on the good promotion/deontological/anti-bribery legal guidelines
  • Understand and ensure compliance to local and international regulations, guidances and laws, company standards and SOPs, company integrity agreements and quality


COMMUNICATION/REPORTING

  • Represent the interest of medical shared services in internal meetings when applicable
  • Ensure international contacts with global teams in med info (US and Europe), GPS in pharmacovigilance, ethics and compliance and GRA-EU for regulatory.
  • Communicate with the business teams on relevant topics (e.g. change in strategies/updates on submissions/safety concerns).


REGULATORY

  • Ensure submission, follow-up and maintenance of Medical Need Programs for the Belgian affiliate
  • Ensure supervision of the Regulatory Manager tasks:
  1. Submission of dossiers for medical products to be registered via MRP or central procedure
  2. Maintenance of licenses of medicinal products registered via MRP or central procedure (e.g. variations and labeling changes)
  3. Coordinate the update of packaging items for registered products to be in compliance with labeling and packaging guidelines (affiliate labeling responsible person)
  4. Provide support concerning regulations and labeling of clinical trial material


AFFILIATE TASKS

  • Represent the Medical Department at external meetings and towards external associations or official bodies (Pharma.be, FAMHP…)
  • Represent the company for official documents (eg contracts) according to delegation of power.
  • Contribute to affiliate risk assessment, policy development and awareness linked to the respective domains of promotional practices, integrity and drug safety


MEDICAL AFFAIRS

  • Become familiar with the therapeutic domains and medical affairs tasks
  • Understand Belgian health care organization
  • Provide expert medical support to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company
  • Support to strategy and provide medical expertise in price & reimbursement dossiers
  • Liaise with Belgian clinical operation manager
  • Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.
  • Contribute actively on an ongoing basis to the strategic planning for currently marketed brands
  • Support training of sales representatives, and other medical representatives
  • Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community

Profile

  • Medical Doctor
  • Excellent leadership skills
  • Having worked in the Belgian health care system and/or experience in medical department/drug safety of pharmaceutical company 
  • Strong interpersonal skills, teamwork, project management, planning and pro-activity
  • Fluent in French, Dutch and English
  • Good presentation skills
  • Proficiency in computer skills and databases
  • Business acumen: ability to balance scientific priorities with business priorities
  • Have a broad scientific interest

Apply now for Pharmacovigilance and Regulatory Affairs Lead Belgium & Luxembourg

Provide your contact information, education and experience so we can quickly see if you are a suitable candidate for the job.

Contact details

Education and experience

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+32 497 71 58 10