Position Purpose Summary
- Lead, manage and provide strategic direction to the cluster Local Medical Safety Team (LMS) team.
- Accountable for all strategic PV activities for the Cluster
- Ensuring that the Local Operating Company Safety activities, related to medicinal and nonmedicinal products are managed in compliance with local regulations and company policies/procedures at a local, regional and global levels and in accordance with any Product vigilance agreements with third party business partners
- Contact point in the country, internally and externally, for safety-related aspects.
- When required by local regulations act as a local QPPV or local responsible/contact person for PV.
- Have appropriate Pharmaco- and consumer product vigilance and Risk management systems in place in order to assure appropriate oversight for products within its responsibility
- Ensure that the team provides input into global and regional strategies to provide optimal support for meeting regional and Cluster business objectives.
- Responsible for the leadership, development, and performance management of the country/Cluster team to achieve company objectives and culture. Develop and enhance the capabilities and capacities of the team through the identification and implementation of training and development needs.
- Where required by regulations, act as local contact or local QPPV, cooperating with the QPPV office and being active member of the Global QPPV Network. Manage local PSMF or equivalent document as needed.
- Maintain expertise in country/cluster as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the cluster
- Act as country’s point contact for Safety, internally and externally
- Support local, internal and external safety activities in collaboration with internal and external stakeholders
- Represent Pharmacovigilance in Cluster/country compliance forums or councils as applicable
- Represent Pharmacovigilance as local Medical Safety Expert in CVTs and business planning, as applicable
- Represent pharmacovigilance and actively participate in local Pharma Association(s) and other external groups, and effectively communicate to key stakeholders of key issues that could impact PV strategies or the business.
- Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network. Respond to spontaneous requests from authorities Acting within the local Pharma Association collaborate with authorities in order to impact pharmacovigilance standards in cluster/country.
- Efficient, high-quality execution of safety-related activities
- Performance towards corporate functions and local compliance towards regulatory bodies
- Efficient management of resources in the Safety Unit In detail:
- Effectively collaborate with Regional IPV Affairs & CM teams to manage workload, as applicable.
- Continuous improvement of safety culture
- Participate in global/regional project and working groups, as applicable.
- Develop and maintain knowledge of applicable SOPs and other procedural documentation
- Manage and monitor the effective rollout of processes
- Facilitate resolution of concerns and questions
- Ensure fulfilling of drug safety-related obligations for the country/cluster in compliance with company standards and international/local regulations.
- Ensure timely and accurate handling of individual and aggregate reports to meet corporate and regulatory reporting requirements for the country
- Ensure timely handling of local safety issues; manage local safety issues in collaboration with global safety functions and local partners
- Ensure adequate local signal detection process if required and ensure reporting of potential single case signals or clusters of similar events seen in case processing, as applicable and in collaboration with Case management team.
- Support timely handling of local safety-related regulatory requests, collaborate with appropriate departments to identify the resources and expertise needed to address the requests.
- Monitor, and actively conduct as needed, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local laws
- Oversight of data generating activities to ensure appropriate review and reporting process are included in project documents
- Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to Global Medical Safety (GMS), OCMS or appropriate case management center and Regulatory Authority (RA), as required.
- Monitor and conduct as needed, local Cosmetovigilance activities
- Organize and manage Audit & Inspection readiness activities in the country/cluster
- Take responsibility for implementing corrective actions resulting from timeliness or quality issues associated with safety-related activities for the country
- Collaborate with the local Marketing Authorization Holders (MAH) to enable fulfilment of its regulatory responsibilities (including Pharmacovigilance Agreement (PVA’s)) and meet their business objectives
- Monitor and manage training of Local Safety Unit, and ensure coaching and mentoring
- Organize and manage recruitment for the Local Safety Unit; fully utilize corporate tools, to manage the performance reviews of assigned colleagues in the country/cluster
- Manage and monitor cost of the cluster team and relevant safety activities
- Busienss Continuity: Ensure creation and implementation of local business continuity plans (e.g. inspection readiness, AE reporting coverage) in collaboration with case management team. Ensure an effective system is in place for 24-hour coverage. Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the LOC level in collaboration with case management team
- Degree / Advanced degree in pharmacy, medicine or in life sciences or equivalent experience
- Good understanding of medical and scientific terminology in both local language and English
- Knowledge and familiarity with industry principles of product vigilance, drug development and pharmacology
- In depth knowledge of national/regional regulatory legislation and guidelines
- Rational approach to issues and their business implications
- Good problem solving and decision-making skills
- Team building and team management experience
- Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork
- Excellent communication and negotiation skills – ability to manage discussions and decision making across cultures
- Highly skilled in time management and change management, organizational and facilitation skills
- Ability to meet personal objectives while meeting departmental standards of performance
- Comfortable working in a matrix environment
- Ability to manage/oversee in country and ex-country pharmacovigilance partners
- Good understanding of computer technology and demonstrated computer literacy particularly in use and management of relational databases
United Arab Emirates-Dubai-Dubai-
Johnson & Johnson Middle East FZ-LLC (8608)
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