30 may
|
PharmaLex
|
Santiago
30 may
PharmaLex
Santiago
Postúlate en Kit Empleo: kitempleo.cl/empleo/1djckq
Job Details
Pharmacovigilance professional with at least 5 years of experience and responsible for the execution of operational tasks and all aspects of technical delivery and project management in the field of local pharmacovigilance.
Responsibilities
- Act as official liaison with the Competent Authority in Chile for pharmacovigilance-related matters.
- Set‑up and oversight of local PV system to ensure compliance with national laws and regulations.
- Notify the health authority promptly of significant safety concerns, product recalls or changes in the benefit‑risk profile of the products.
- Coordinate the distribution of national safety communications, such as Direct Healthcare Professional Communications.
- Internally, serving as point of contact for the integral PV team.
- Execution and oversight of Local Literature strategies.
- Execution and oversight of Local ICSR Management process.
- PV Intelligence Screening.
- Contributing locally to the maintenance of the PSMF.
- Pharmacovigilance management of local Organized Data Collection schemes (Patient Support Programs and Market Research initiatives).
- Local PVA Management.
- Local adaptation and submission of PSUR / RMP.
- Implementation of additional Risk Minimization Measures.
- Participate in PV‑relevant audits and inspections.
- Ensure PV training of affiliate employees, service providers and Third Parties.
- Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures.
Educational Requirement
- University degree in Life Science (Health Care professional).
- Several years’ experience and profound knowledge in the field of pharmacovigilance.
- Expertise, experience and knowledge regarding relevant legislative and non‑legislative guidelines on pharmacovigilance.
Minimum Skills, Knowledge And Ability Requirements
- Demonstrable ability in leading, mentoring, managing and motivating staff (team l
Postúlate en Kit Empleo: kitempleo.cl/empleo/1djckq
📌 Manager Local Pharmacovigilance (Santiago)
🏢 PharmaLex
📍 Santiago