Country Patient Safety Head
Novartis
- Metro Manila
- Permanent
- Full-time
- As defined by local regulations act as the National/Local Qualified Person or Local Contact Person for Pharmaco-device vigilance in the country (ies) and act as the single point of contact with the Local Health Authority on a 24-hour basis concerning Pharmaco-device vigilance matters]
- Act as the CPSH for all Novartis divisions and group companies [CPSH may delegate the activities to a deputy (CPSH Deputy) but the ultimate responsibility remains with the CPSH. Delegation should be clearly detailed]. Key member of the local leadership team and/or influencing local leadership team to assure the country is meeting its regulatory obligations to the local health authority. Partner management at a senior level in the local organization and at the global level in PS.
- Ensure oversight of the structure and performance of Novartis PV System at local level, in order to promote, maintain and improve compliance. Ensure access to all information sources maintained to lead all aspects of structure and performance of the PV system at local level.
- Monitor internal compliance for local processing and external compliance (regulatory reporting) according to defined timelines. Ensure that locally delayed safety cases or aggregate reports are properly captured, investigated and root causes addressed through any corresponding corrective/preventative action. Notification and escalation of any late case/submission to Pharmaco-device vigilance Compliance (PVC) and to QPPV/Countries & Regions.
- Supervise and assess the performance and efficiency of PV 3rd parties in line with the applicable regulations, agreements and standard operational/ working procedures in place. In collaboration with QA and Vendor Management functions, ensure corrective and/or preventive actions are implemented in case contractual commitments are not met, as applicable.
- Drive the local impact assessment of new local pharmacovigilance-related legislation and provide support to Global PS organization on local PV matters and local change impact. Ensure the local Pharmaco-device vigilance requirements are met. Ensure Novartis tools/systems configurations are in line with the country-specific requirements to guarantee that the Country Organization receives all the safety information needed to meet local legislation
- In collaboration with Regulatory Affairs (RA), ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities; ensure alignment with Global Line Functions/ QPPV office in all safety-related responses, as applicable. In cooperation with the QA applicable groups, lead any local Pharmaco-vigilance inspection and/or Pharmaco-device vigilance audit and proactively, cooperate in the implementation of any corrective/ preventative action as determined by auditors/ inspectors. Contribute as Pharmaco-device vigilance SME, in other internal Novartis audits and/or third party audits, as required.
- Contribute for the continuous monitoring of any emerging safety concerns at local level affecting the safety profile of the medicinal products for which Novartis group of companies MAHs hold authorizations. Collaborate together with RA in the implementation of urgent regulatory actions at country level, as required. Ensure the country oversight of Patient Oriented Programs (POPs) held at local level, in line with Novartis procedures and applicable regulations/ standards/ guidelines. Act as the operational manager of the POP Champion Lead/ Manager/ Specialist for the country
- Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience
- 8-10 years of working experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
- Good knowledge of regional and local requirements relating to patient safety
- Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training.
- Ability to lead and provide guidance and direction to team members.
- Critical thinking, Quality & Focus Oriented
- Ability to lead, plan and prioritize activities simultaneously.
- Good communication and networking skills