Key4Nova is committed to providing the best HR services for organizations within Life Sciences & Healthcare, Consumer and Industries. For both permanent and temporary positions, you can rely on us to deliver the best candidates for even the hardest positions. From professional to top executive level, whether it concerns General Management, Sales & Marketing, Quality, Regulatory, Research & Development, Logistic, Production, Finance, Clinical or Medical Affairs. We are looking for our client :
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 cross-functionally 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 web-based 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 time-management skills, able to prioritize work and adhere to deadlines
- Excellent communication skills
- The capacity to maintain a positive, result oriented work environment
Autres informations:
Being located in Belgium and a having a decent level of French is mandatory for this role.
Benefits
- Work Remotely
- Get involved in interesting projets
- Join a company that values their employees equally
- Integrate a multinational environment of more than 30 nationalities
