Pharmacovigilance Qppv Manager - Brussels, België - Key4Nova

Key4Nova

Geverifieerd bedrijf

Brussels, België

4 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Pharmacovigilance QPPV Manager (Remote - Freelance)

Poste:

Act as the EU QPPV (Qualified Person for PV) and/or deputy EU QPPV on assigned projects
Act as a local qualified/contact person for pharmacovigilance
Manage a group of PV specialists, PV associates, PV assistants within the assigned projects
Organize meetings with project members
Ensure the delivery of projects/tasks in accordance with client needs as per the contractual agreements and procedures in place;
Follow and achieve agreed personal KPIs and KPIs of the department
Act as a process owner for assigned PV processes assigned by the Team Lead
Provide training to project team members and other PV department employees on technical areas as needed
Improve teamwork collaboration by sharing best practices
Properly escalate to management all unresolved issues or identified improvements proposed for implementation;
Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication, ensuring full compliance with the processes and project deliverables
Work crossfunctionally and in collaboration with key stakeholders/customers, both internal (Commercial, Technical, Quality, Regulatory, Pharmacovigilance,...) and external (Competent Authorities, Clients, External Vendors,...)
Participate in business meetings, bid defences with current and potential clients
Participate in company marketing and promotional activities, if required
Participate in audits and inspections

Profil:

You have

A Bachelor's degree, Master degree or graduate in pharmaceutical sciences or related fields (Medicine, Pharmacy, Life Sciences, )
A minimum of 4 years of experience working in a medical or safety department with demonstrable expert knowledge of medical terminology
A detailed knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS,...)
An experience working with a safety database desirable
Knowledge of webbased communication tools for conferencing (Skype/Teams, WebEx, etc.)
A fluent verbal and written English & French
The ability to delegate and oversee work of junior staff
The ability to provide training to junior staff
The mindset of anexcellent team player, able to build an effective team
Organizational and timemanagement skills, able to prioritize work and adhere to deadlines
Excellent communication skills
The capacity to maintain a positive, result oriented work environment

Autres informations: