Job Opportunities in Poland
October 15, 2024
LEO Pharma A/S
Gdańsk
OTHER
Pharmacovigilance & Safety Team Leader
Field of work: Clinical Development
Posting Date: 14 Oct 2024
Location: gdansk 80-309, Poland, Poland
Contract type: Permanent
Job ID: 2604
Contract type: Permanent
Job ID: 2604
Role Description
Shape the LEO Pharma of tomorrow
At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide.
In Global Safety Case Management (GSO) we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.
Together with the e GSLT (extended Global Safety Leadership Team) you will set the strategy for Global Safety and together with the Head of GSO, set the direction for GSO, and prepare an action plan and ensure implementation. You will also influence decisions on GSO level, and in- and outside imme- diate stakeholder areas.
Your role
You will develop and direct the case handling process for all LEOs global clinical trials and product new to market and drive systematic improvement hereof.
- Manage and lead a team of Global Safety Specialists (employed and contracted) overseeing workload, maximizing resources and building capabilities.
- People and performance management incl. performing regular 1:1s and LEO GROW talks
- Mentoring, training, and coaching team members
- Ensure implementation and compliance of training of team members
- Be globally responsible for case processing on all LEO’s products in the clinical development (topicals, systemics and biologics) and new- to- market products
- Allocate qualified participation in all trial teams and pro- jects as relevant
- Ensure the implementation of clinical development pro- grammes in GSO
- Lead GSO in all steps of case processing for clinical trial cases received from all investigational sites globally and cover cross-clinical programs and projects from an oper- ational perspective.
- Lead GSO in all steps of case processing for all new-to -market products received from all sources
- Facilitate Cross-functional and cross-departmental col- laboration with regards to clinical trials conduction
- Actively participate in global and local networking group
- Apply advanced knowledge of Safety Operation to perform Global Drug Safety Specialist tasks in GSO, if re quired
- Establish and maintain process for handling of adverse event cases related to medical devices
- Contribute in implementing and maintaining a strong process for handling of incidents (originated from medical devices) in LEO Pharma with focus on quality of safety data
- Responsible for on time reporting and tracking of global cases according to global PV regulatory requirements
- To oversee the compliance and QMS
- Supervise, review, and approve deviations related to case processing in GSO, implementing corrective and preventative actions.
- Represent GSO and coordinate tasks within and outside Global Safety and Regulatory Affairs
- Collaborate with other managers in Global Safety to ensure harmonization and optimization of work practices.
- Maintain operational partnership relations with external partners
Your qualifications
To succeed in this role, we imagine that you have the following qualifications:
- Degree in health or biological science: MD, MSc, MSc Pharm, or equivalent
- A minimum of 3 years of drug safety experience including experience with post-marketing and clinical trial case processing.
- Good leadership and management capability and expe- rience with mobilising teams to meet agreed objectives and targets
- Strong computer literacy and knowledge of safety data- bases
- Deep understanding and application of Global Regula- tory (ICH/FDA/EMA) guidelines in a safety environment
- In depth understanding in Pharmacovigilance, Adverse Event (AE) and Other Experiences (OE) handling and re- porting
- Drive for improvement, flexible thinker, to enable resource fulness in issue resolution, decision-making and integra- tion of new case handling systems and processes
- Able to handle diverging interests in order to find solutions and influence the stakeholders’ decisions regarding PV
LEO Pharma is built on collaboration, innovation and curiosity. Is this you? Can you bring this and
Excellent communication, influencing skills and demon- strated credibility
High level of accuracy, integrity and quality in work prac- tices
Your application
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.
Your benefits
Working at LEO Pharma will give you access to a wide range of benefits that, among others, include:
- Annual bonus
- Private medical package
- Life insurance
- Access to Learning Platform
- Sharing the cost of professional trainings and courses
- My Benefit platform (flex benefit program with Gym Pass included)
- Support of work-life balance (flexible working hours, hybrid work opportunities)
- Employee Referral Program
- Extra social benefits (e.g., vacation allowance)
- Supportive community and integration events.
- Eco-friendly office environment with fresh ground coffee and fruits
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