The Specialist Local Medical Safety, Korea (PV Specialist) is responsible for managing local medical safety activities to ensure proactive benefit-risk management throughout the product lifecycle, while supporting pharmacovigilance requirements in compliance with MAH and/or study sponsor obligations.

Key Responsibilities

• Ensure that day-to-day PV activities and safety activities are performed satisfactorily.
• Collaborate with the local Marketing Authorization Holder (MAH) to enable fulfilment of its regulatory responsibilities and meet their business objectives
• Manage and implement local Pharmacovigilance Agreement (PVA’s)
• Support activity owners in including appropriate PV language in vendor contracts to ensure safety obligations are met as applicable
• Ensure proper handling of Health Authority (HA) safety related queries (communication, response, and escalation).
• Communicate with the HA, when applicable, to clarify requirements in support of LMS-wide policy, process harmonization/improvement
• Ensure business continuity to safeguard compliance
• Provide support to the Related Research Activities Center of Excellence (RRA CoE) for local Related Research Activities (RRA).
• Collaborate with project owners and LMS operations to provide input for the reporting process of potential AEs included in local data generating activities to ensure appropriate safety monitoring 

LOCAL BENEFIT-RISK ACTIVITIES

Medical Insights

• Establish Product knowledge with focus on safety profiles, Therapeutic Area (TA) and Disease Pathway knowledge, supporting the needs of the local Medical and Commercial organization, in collaboration with the Risk Management Leads and LMS product team as applicable.
• Participate in the TA and Product local cross-functional teams to contribute safety insight for strategy development, act as a safety expert in team meetings, communicate relevant safety information for LOC stakeholders and perform training on safety relevant aspects, as appropriate

Local Product Compliance Related Activities

• Conduct the local product compliance related activities in collaboration with stakeholders as needed.
• Communicate new relevant safety information available in a timely manner to GMS and to LOC stakeholders as per procedure
• Support internal discussion of Risk Management Plans (RMPs)/ Addendums with local stakeholders, participate in local implementation of RMP including additional risk minimization activities and
  negotiate with local HA to reach agreement, etc., as applicable
• Prepare local RMP/Addendums based on internal alignment and local/global procedures as required

LOCAL REGULATORY REQUIREMENTS

• Ensure awareness of new/changes in local PV regulations and evaluation of the impact on local/global processes and notification of appropriate local, regional and global groups
• Perform procedural document impact assessment and support implementation of Global PV relevant Procedural Documents, as applicable
• Implement new or updated PV regulations, as needed
• Provide input into requests for information in support of the development of LMS-wide processes, systems, and policies

Qualifications

• Bachelor’s degree or above in Health, Life Sciences, Pharmacy, or related field
• Pharmacist license preferred

• Minimum 2+ years of experience in pharmacovigilance or related areas(e.g., CRA, MIS, Hospital Pharmacist)
• Prior PV experience preferred