Senior Safety Officer

Job Position: Senior Safety Officer Supporting South Korea market. Location: Level 8, The Pinnacle, Persiaran Lagoon, Bandar Sunway, 46150 Petaling Jaya, Selangor Darul Ehsan, Malaysia POSITION SUMMARY: The Senior Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all 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. This role will act as the Local Operating Company (LOC)’s and assigned territories (as applicable) main point of contact for pharmacovigilance matters with the local health authority. They will ensure that appropriate product vigilance and risk management systems are set in place to assure appropriate oversight of products within its responsibility. PRINCIPAL RESPONSIBILITIES: 1- Act as Local Nominated Person (including back-up nominated person) Function as nationally nominated person for Pharmacovigilance in respective countries assuming the PV role as defined by national law. Collaborate with the QPPV offices as required. 2- Oversight of the PV System & Overall responsibilities • Provide oversight of vendor resources in the countries in scope. • Support the Area Safety Head in providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files. • Perform other agreed tasks assigned by manager. 10% • Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs. 3- Safety Management & Reporting • Receive and support the Area Safety Head in the responses to safety related health authority queries in the territory. • Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders). • Maintain oversight of proper identification of local literature articles for AE reporting as required. • Perform document management and archiving as required. • Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general. • Perform regulatory monitoring for impact on vigilance activities and responsibilities. • Collaborating with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals. • Manage reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other client departments as applicable. • Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements. • Ensure pharmacovigilance compliance of local company sponsored programs and research activities as applicable. • Perform translation for ICSR and PV-related documents, as required 50% 4- Collaboration & Support Provide technical and strategic input and participate in projects/ workstreams led by the KMS teams or LOC 10% 5- Procedural Document • Develop, update, and implement local procedures to ensure compliance with client global procedures and national requirements. • Ensure current knowledge of all relevant company procedures and training. 5% 6- Audit & inspection readiness Support local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable. 5% 7- PV contract management Management of PV clauses to be included within local agreements. 15% 8- Business Continuity Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage). 5% Other Duties: Describe important tasks or duties, not mentioned above, that are performed infrequently and are not critical to accomplishing the essential functions of the job. Enter “N/A” if no additional duties need to be listed. N/A Qualifications: Describe the minimum knowledge, skill, related experience, and ability requirements for the position. Education: Health care science professional e.g.: (preferably Physician or Pharmacist) Years of Related Experience: At minimum 3 years’ experience. Knowledge, Skills, Abilities: Include any required computer skills, certifications, licenses, languages, etc. • Pharmaceutical industry experience including product vigilance responsibility role. • Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field. • Proven ability to organize workflow activities. • Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology. • Knowledge of global, regional, and local procedural documents as applicable. • Computer literate with knowledge of relevant IT safety systems. • Good verbal and written communication skills. • Ability to establish and maintain open relationships within the organization and with authorities. • Demonstrable knowledge of all local requirements and of global aspects of product safety. • Fluency in the Korean and the English language.