Senior Medical Safety Operations Leader Mechelen (BE)

Vacature in het kort

Join our dynamic Biotech company in a crucial interim leadership role within Safety Operations. You'll lead operational activities, ensuring compliance and safety in product development. This role involves guiding a team through clinical trial safety, post-marketing pharmacovigilance, and process improvements. You'll also support signal management, oversee CRO compliance, and contribute to PV infrastructure projects. Enjoy a balanced salary package with extra legal benefits in a role that promises to be both challenging and rewarding. Uncover the reasons why this position could elevate your career.

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Are you an expert in Drug Safety and Pharmacovigilance with leadership skills? Do you want to take on the challenge for an interim leadership role within Safety Operations in a dynamic, growing Biotech company? Don't hesitate and apply now!

Job description

The Medical Safety Operations Leader will report to the Head of Medical Safety and will lead all related operational activities to ensure compliance with all relevant regulations and to ensure safety of product development.

The Medical Safety Operations Leader will be an interim leadership role including providing direction for the operations department in a time of change and exciting product development.

Responsibilities include leading a small team to ensure operational compliance and excellence in clinical trial safety and post-marketing pharmacovigilance, inspection readiness, support for audits and inspections, leading process improvements including SOP, WI document guidance, CAPA and quality oversight and supporting signal management.

Responsibilities:

• Lead safety operations with support of a small team
• Lead team to ensure adherence to all global required regulatory requirements.
• Ensure that processes are in place to identify changes in regulatory requirements.
• Ensure that the operations team is aware of any relevant PV regulatory updates and that appropriate action is then taken.
• Lead process improvements within safety and cross-functionally to improve compliance as needed.
• Ensure oversight and monitoring of CRO compliance through various monitoring activities.
• Ensure resourcing of operational support is in place to allow safety operations to support clinical development activities
• Support the development of PV infrastructure including new safety projects, and set up applicable safety systems.
• Serve as internal PV quality contact and provide support for external and internal audits and inspections.
• Oversee deviation and CAPA activities
• Represent the Medical Safety Department in cross-functional meetings or working groups as needed.

Requirements:

• Pharmacist, Nurse, or a Life Sciences degree (equivalent work experience).
• 10+ years of experience in various drug safety and pharmacovigilance positions (clinical trials and post-marketing), with increasing seniority and including leadership experience within safety operations
• Set up / oversee safety requirements for US as well as EU / UK requirements. Other agencies globally would be a plus.
• Experienced in preparing teams for, and leading teams through European and FDA inspections (GVP and GCP) and subsequent corrective and preventive actions.
• Experience in leading process improvements within safety departments and cross functionally.
• Experience in a matrix environment, interaction with stakeholders with different background and ability to adapt to corporate culture are essential.
• Ability to adapt to rapidly changing environment and think strategically in terms of both departmental and company objectives.
• Needs to be able to work at least some time each month in one of our three offices, including as agreed for key meetings.
• Previous safety science experience in addition to safety operations is a plus.
• CAR-T or other cell therapy or gene therapy is a plus.
• Experience in leading MAH transfer or database migration is a plus.

• Broad knowledge of pharmacovigilance needs within a drug development environment.
• Expert knowledge of general drug development process.
• Expert knowledge of ICH (International Council on Harmonisation of Technical Requirements), GCP (Good Clinical Practice), GVP (Good Pharmacovigilance Practice) and other regulatory requirements applicable in the pharmacovigilance domain.
• Excellent team player, able to deliver against a tight deadline and in a demanding environment.
• Flexible mindset. Ability to make things happen and take ownership.
• Very good technical and organizational skills.
• Communication Skills.
• Excellent writing and communication skills both towards team members within the company as towards external contacts.
• Ability to negotiate and influence.

• Fluent in English, working knowledge of other international languages beneficial.

• Existing right to work in Europe is required.

Benefits

• Fulltime position.
• Location: Mechelen, Basel or Leiden.
• A balanced salary package based on your capabilities and experience, including extra legal benefits.

Vacancy number: 24582