[Innovative Medicine] PV Specialist

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Product Safety Job Sub Function: Pharmacovigilance Job Category: Scientific/Technology All Job Posting Locations: Seoul, Korea, Republic of Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine The Specialist, Local Medical Safety, Korea (PV Specialist), is responsible for managing day-to-day pharmacovigilance (PV) activities in compliance with local regulations and company policies and procedures at the local, regional, and global levels. The role also supports local medical safety activities to ensure proactive benefit-risk management throughout the product lifecycle. Key ResponsibilitiesICSR MANAGEMENT AND OVERSIGHT Ensure local collection, review, reporting, reconciliation, and follow up on Individual Case Safety Reports (ICSR). Manage and maintain active involvement in day-to-day ICSR management related activities as applicable. Ensure implementation of local literature process. Maintain oversight of corresponding vendor activities as required. COMPLIANCE ACTIVITIES Ensure PV audit/inspection readiness at the LOC level at all times. Maintain oversight of ICSR inbound and outbound compliance. Increase PV compliance awareness and business relevance with stakeholders and ensure appropriate ownership of PV-related findings and Corrective Action/Preventive Actions (CAPAs). Escalate compliance issues in a timely manner to Country/Cluster Safety Head (CSH), to ensure appropriate mitigation is implemented. Address follow-up actions from Local Safety unit (LSU) owned non conformances, including LSU related CAPAs AGGREGATE REPORTING Review, translate (if applicable), prepare, submit and track aggregate reports as required by local regulations and ensure compliance oversight requirements are met PHARMACOVIGILANCE SERVICE PROVISION 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). 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 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 Qualifications Education Bachelor’s degree or above in Health, Life Sciences, Pharmacy, or related field Pharmacist license preferred Experience Minimum 1~2 years of experience in pharmacovigilance or related areas(e.g., CRA, MIS, Hospital Pharmacist) Prior PV experience preferred Skills & Competencies Excellent verbal and written communication skills Fluency in the national language(s) and the English language required Ability to effectively communicate and negotiate with internal and external customers. Ability to establish and maintain relationships within the organization and with authorities Excellent analytical skills to identify gaps and root causes of issues and think out of the box to develop a solution. Must be able to work independently with minimum supervision while meeting tight deadlines #LI-Hybrid#LI-SK3 Legal Entity Innovative Medicine Job Type Regular Application Documents Free-form resume AND cover letter is required (in Korean or English). Application Deadline Open until the position is filled. Notes Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws. Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances. If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted. Submitted documents will not be returned and will be deleted upon request. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered Required Skills: Preferred Skills: Analytical Reasoning, Clinical Operations, Collaboration, Cross-Functional Collaboration, Detail-Oriented, Execution Focus, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technologically Savvy