Global Safety Surveillance Manager

Job title:

Global Safety Surveillance Manager

Company:

Leo Pharma

Job description

Application deadline:
Location: Ballerup 2750, , Denmark
Contract type: Permanent
Job ID: 2916Are you a dynamic leader with a passion for pharmacovigilance and safety? LEO Pharma is seeking a talented Global Safety Surveillance Manager to join our team. In this role, you will lead and manage a team of Global Safety Advisors and Safety Leads, ensuring compliance, optimizing resources, and building capabilities. This is an opportunity to make a significant impact, contribute to patient safety, and drive the success of LEO Pharma’s global safety surveillance.Your Role
As the Manager Global Safety Surveillance, your objective will be to manage and lead a team of Global Safety Advisors and Safety Leads. Your role will involve ensuring compliance with pharmacovigilance processes, regulations, and guidelines, while setting the strategy for Global Safety Surveillance and leading implementation initiatives.

• People and performance management, including regular 1:1s and performance discussions.
• Mentor, train, and coach team members.
• Ensure implementation and compliance with training for team members.
• Ensure safety risk management, signal detection, case handling activities, and aggregated report writing for assigned products/projects are carried out timely and in compliance with regulatory requirements.
• Ensure preparation of responses to Regulatory Authorities and other parties.
• Ensure input and contribution is provided to clinical trial activities (e.g. clinical trial outlines, protocols, IBs, patient information leaflets, clinical trial reports)
• Ensure preparation of PV-specific documents for regulatory submissions (e.g., RMP).
• Represent the department in cross-departmental teams.
• Communicate safety issues internally and to health authorities.

Your Qualifications

• University degree in health or biomedicine science (MD, MSc, MSc Pharm, or equivalent) with a minimum of 4 years of experience working in a project-oriented, international organization, preferably in Pharmacovigilance.
• Strong leadership and management capability, with experience mobilizing teams to meet objectives and targets.
• Excellent communication and influencing skills, with demonstrated credibility.
• Strong medical/scientific knowledge and evaluation skills, including signal evaluation and trending.
• Strong understanding of global regulatory requirements (EMA/FDA/ICH).
• Strong data analysis and interpretation skills.
• Medical and scientific writing skills.
• Understanding of clinical/drug development processes and functions.
• Fluent verbal and written English.
• Strategic thinking, influencing, and collaboration skills.

Your New TeamYou will be joining a highly skilled and collaborative team of Global Safety Advisors and Safety Leads in the Global Safety Surveillance department. Together, you will work towards ensuring compliance, optimizing safety processes, and upholding the highest standards in pharmacovigilance. As a Manager, you will have the opportunity to lead a team up to 10 people and inspire them, fostering a culture of excellence and continuous improvement.Contact and ApplicationReady to take the next step in your career and join a company committed to improving the lives of people with skin diseases? Apply now and become a part of our journey to advance dermatology beyond the skin.
You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.Beyond the skinJoin LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.For certain positions, LEO Pharma might complete a background check conducted by a third party.

Expected salary

Location

Ballerup, Hovedstaden

Job date

Sun, 09 Feb 2025 07:27:11 GMT

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