Ifi Pharmacovigilance Manager

4 giorni fa

Roma, Lazio, Italia Leo Pharma Inc. A tempo pieno

Select how often (in days) to receive an alert: Are you an experienced Pharmacovigilance Manager with a strong background in pharmacovigilance, team management and a passion for ensuring patient safety?
Do you thrive in a dynamic environment where your expertise can drive collaboration and support global safety initiatives?
At LEO Pharma, we are committed to helping people achieve healthy skin through innovative treatments.
We invite you to join our Safety team in Paris Area, where you will play a crucial role in supporting the development of a global pharmacovigilance system.
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 the Global Safety & Regulatory Affairs team we share a "challenge accepted" mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.Your roleAs ourPharmacovigilance Manager , you will align with the strategic direction set by the Global Safety & Regulatory Affairs team.
This involves establishing and maintaining both Global and Local Standard Operating Procedures to ensure compliance with international and national regulations.
You will support the company's business strategy through both short- and long-term tactical actions, considering local obligations and strategic goals.
Your main missions will include ensuring the performance and compliance of your business area (IFI : Italy, France and Iberia), defining new processes and standards to secure the operating authorization of the Exploitant, managing workload, optimizing resources, and developing necessary skills.
Additionally, you will ensure the availability of appropriate capabilities, maintain the continuity of pharmacovigilance activities, and serve as the Safety Contact Person (SCP) in France.
Some of the key responsibilities will include, but are not limited to : Team's management :Manage, guide, develop, and lead direct reports, including performance management and orientation; ensure and monitor the implementation and compliance of the team's training programs.
Conduct interviews, initiate hiring processes, and plan for succession of PV staff in France, Iberia, and Italy.
Ensure deliverables and effective performance management of local pharmacovigilance operations.
Act as a liaison between local and global levels, communicating transformations and changes related to the local pharmacovigilance organization.
Collaborate with employees and managers of the GSRA teams.
Local Safety Operations :Contribute to the Global PSMF in a timely manner.
Oversee the local PSMF in France and be available upon request from the health authorities (ANSM).
Ensure the implementation of a continuity plan.
Serve as the PV interface with local health authorities.
Oversee PV training for LEO Pharma partners and employees.
Lead audits and inspections in France and support audits and inspections in Spain and Italy.
Identify and implement improvements for pharmacovigilance operations and procedures.
Ensure the timely processing of pharmacovigilance information for spontaneous or solicited cases.
Perform reconciliation of PV cases when necessary.
Ensure regulatory reporting of cases from interventional clinical trials, including DSUR.
Conduct regulatory surveillance of PV.
Manage PV for patient support programs, market research, and stay informed about investigator-initiated studies, while communicating on initiatives.
Ensure PV contracts are in place.
Inform relevant personnel and issue alerts in case of potential signals.
QualificationsTo succeed in this role, we imagine that you have the following qualifications: Pharmacist or medical degree, with a minimum of 6 to 8 years' experience in pharmacovigilance.
As a SCP: resides and carries out activities in France.
Strong leadership and management capabilities.
Understanding and application of local and European pharmacovigilance and clinical process for PV regulations.
Written and spoken English full proficiency.
We are seeking a candidate with exceptional communication and influencing skills, recognized for their expertise in partnering with senior roles across the organization and team management.
The ideal candidate will have a proven ability to plan and prioritize activities, ensuring that commitments are met and deliverables are achieved.
They should possess a strong action and goal-oriented mindset, and be adept at applying business and market knowledge to effectively advance the organization's goals and have an aptitude for embracing change.
Your new team Join a dedicated and passionate team within the Global Safety & Regulatory Affairs department at LEO Pharma.
Our collaborative environment promotes innovation, learning, and professional growth.
You will lead a team of 5 PV officers and you will work closely with internal stakeholders from Medical Affairs, IFI Quality Assurance, GSRA, Medical Information, Legal, and Commercial departments.
Additionally, you will manage relationships with external entities such as ANSM, LEEM, AFAR, and health authorities.
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.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.#J-18808-Ljbffr

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