Country Safety Head Korea

The CHC PV Country Safety Head (CSH):

• Is responsible for a country.
• Serves as the local PV contact for the authorities, is accountable for PV inspections and is nominated as local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations. Designate a back-up who replaces him/her when he/she is out of the office
• Is recognized as the key leader for all PV related activities at country level, including but not limited to case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs market research programs for PV aspects.
• Ensures that local PV activities in the assigned country are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country.
• Establishes and maintain robust and efficient local PV systems in the designated country by ensuring the availability and implementation of proper systems/procedures tools and training. Support the QPPV in overseeing the PV activities in the country.
• Supports the CHC Head of  Consumer Safety with regards to local budget planning and maagement.
• Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager.
• Acts as CSH Backup for other country, where needed.

Main Responsibilities

Local and Global Partnership

Local:

• Represent PV in interactions with local GxP and non GxP functions, to optimize coordination and collaboration in areas of overlapping interests:
• Build and maintain robust collaboration/interaction with the in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines, and particularly.
• Build and maintain robust working relationship with local external PV vendors as well as Global PV vendors operating local activites.

Global:

• Identify issues or dysfunction in the assigned country(ies) and escalate to senior PV Management,
• In case of local PV outsourcing activities, collaborate with Global PV to implement the best outsourced capabilities
• Interact with Global PV for any questions related to the safety profile of CHC products originating from HA or any other sources

Organization and maintenance of local PV Quality system

• Establish and implement processes in compliance with regional/local PV regulations and global procedures and cooperate with the local Quality Head to document them in local Quality Documents as appropriate
• Ensure maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements.
• Develop and maintain the local PV System Master File for the assigned country as required and in accordance with local regulations and the global standards.
• Ensure that education and training on PV and relevant safety topics within the local organization are performed including documentation of attendees and topics covered (i.e. PV Awareness, training of service providers and manufacturing sites)
• Manage local compliance metrics generation and ensure data capture in the appropriate tools.
• Document PV process non-compliance to include investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and coordinate related tracking activities with local Quality Head.
• Warrant audit and inspection readiness of the local PV systems (auditable trail of all PV activities performed in the country is maintained and readily available) with key stakeholders (i.e. Quality, Medical, Regulatory)
• Complete in timely manner audit and inspection observations in close interaction with Global /Local Functions

Organization and Maintenance of PV Operating & Safety Management System

In compliance with PV regulatory requirements and company procedures/guidelines,

• Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to Global PV Operations and subsequently to external stakeholders, such as HAs, partners.
• Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs ,
• Ensure screening of local scientific / medical literature and management of relevant abstract/articles
• Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program...), and company sponsored digital media
• Ensure screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes
• Secure that for all global/local Business Partner agreements, requiring safety provisions, a local SDEA or PV Clause is set-up, implemented and maintained as appropriate.
• In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), Manage contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations
• Support the Global PV and particularly the QPPV with local safety surveillance activities
• Handle/escalate product safety alerts in timely manner
• Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert. Track the actual implementation of additional Risk Minimization Measures (aRMMs) in the assigned country.
• Ensure that PV unit is involved in reviewing relevant safety sections of local documents, owned by other affiliates entities, such as labeling, contracts with third parties and local study protocols.

About you 

SKILLS, EXPERIENCE AND KNOWLEDGE REQUIREMENTS:

Competencies

• Knowledge of national PV regulations and international regulations regarding safety requirements as well as industry standards
• Pragmatic, solution oriented mindset; problem-solving, prioritize, take initiative and meet challenges
• Good written and verbal communication skills. Good level of speaking/writing English.

Education

• Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master Degree with three or more years of pharmacovigilance/clinical development experience.

Experience

• Experience with pharmacovigilance systems and safety related product management
• Appropriate experience with Regulatory Agency interactions

Cultural traits / P2W Behavior

• Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment
• Put the interest of the organization ahead of own of those of his/her team: consider both short and long term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level
• Act in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings the local perspective into decision making.
• Be pro-active action and do not wait to be told what to do.
• Required Leadership Competencies
• Strategic Thinking - ability to evaluate relevant areas of operation, formulate objectives and set priorities in a contextually relevant way, and support the development of plans consistent with long-term organizational interests
• Interpersonal relationships - treating others with courtesy, sensitivity, and respect.
• Change Leadership - The ability to demonstrate support and drive for innovation and organizational transformation
• Personal Leadership - Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust, and accountability.  Ability to put patient, stakeholder, and organizational interests above personal interests
• Drive -Takes the lead and initiates activities with a high degree of passion and commitment as well as the drive, desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellence
• Learning Agility – Ability to navigate first time/unfamiliar situations effectively by extrapolating from other areas of expertise and knowledge. Ability to continuously improve and develop.