This role is open for trilingual PhDs/Pharmacists (NL/FR/EN) with an internship/1st working experience in SAE processing/drug safety/pharmacovigilance.
This is an hybrid working opportunity : this role requires to work on-site for at least 2 days/week, on Tuesday & Thursday.
The Pharmacovigilance Specialist is responsible for managing adverse event, including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring.
Other responsibilities may include but are not limited to: PV intake, management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, SOP management, local training, communication of safety issues, people development, special projects as assigned.
- Serves as the point of contact for the local Health Authority for PV related questions when assigned by the PV Lead and in their absence.
- If serving as the local QPPV/Local PV Contact/Local Responsible PV Person or Backup, complies with all requirements mentioned in the local laws and regulations.
- May be responsible for management of one or more direct reports including recruitment, training, development, and performance management as applicable.
- Responsible for the execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
- Serves as an SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
- Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our client's products in compliance with Corporate Policy 01: Patient Safety.
- Participates in and supports audits of contractual partners/vendors, coordinates the preparation of necessary corrective actions locally for late reporting countries covered by the country operation.
- Supports PV Lead in maintaining the local PV Training matrix and onboarding plans as assigned.
- Supports the development and maintenance of local PV controlled documents (e.g., Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current.
- Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
- May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with business partners, vendors and Alliance Managers as required, performing local qualification/due diligence activities, compliance reviews, and ensuring maintenance of the business partner data tracking system.
- As delegated by PV Lead, collaborates with internal stakeholders to ensure local implementation of Post approval Safety Monitoring Program (PSMP) plan in compliance with local legislation (as applicable).
- As assigned by PV Lead, responsible for scheduling and coordinating submission activities for PSURs and other Aggregate Reports to the local Health Authority in compliance with company procedures and local legislation (as applicable).
- As assigned by PV Lead, responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures locally as per department policy and ensures compliance with local legislations.
- Serves as local Subject Matter Expert on relevant PV regulations, processes and procedures.
- PhD or Pharmacy degree with a first experience in SAE processing, drug safety or Pharmacovigilance within the pharmaceutical industry
- Very good knowledge in the 3 following languages : Dutch, French and English
- Knowledge of AE reporting requirements and relevant PV regulations/PV quality management systems/PV processes and activities.
- Strong leadership, communication, decision making, and problem-solving skills
- Excellent interpersonal communications, organizational, and presentation skills
- Excellent negotiation and influencing skills
- Ability to work in partnership with others (internally and externally) to accomplish quality goals
* A balanced salary package based on your capabilities and experience
* Full-time opportunity
Vacancy number: 23510