Local Safety Senior Associate (1 Year Fixed Contract)

Job description

Career Category Safety Job Description LOCAL SAFETY OFFICER, SENIOR ASSOCIATE (1 YEAR FIXED CONTRACT) Job purpose: Support the effective operation of Global Patient Safety activities in Türkiye by conducting core local safety activities in accordance with applicable legislation, Amgen policies and procedures, and assigned responsibilities. Collect, process, distribute and submit individual and periodic safety reports accurately and on time, using the relevant safety databases and systems. Partner with the Safety Country Lead and local teams to maintain compliance, support safety training and provide safety expertise to the local business. Identify, priorities and escalate safety issues, and contribute to inspection readiness and continuous improvement across local safety operations. Key Responsibilities • Timely and accurately capture, route, translate and follow up adverse event reports received in Türkiye for inclusion in the Global Safety database. • Assist with timely submission of reportable adverse event reports and distribution of periodic safety reports for local or regional requirements. • Support the dissemination and tracking of urgent safety communications, including DHPCs and DILs, and risk minimization measures in line with local requirements and Amgen decisions. • Maintain current knowledge of local pharmacovigilance regulations and work with the Safety Country Lead to keep local requirements, reporting obligations and procedures reflected in GPS SOPs and manuals. • Ensure local safety activities are documented and filed or archived in accordance with Amgen and GPS policies and procedures. • Assist with training customer-facing employees and other relevant staff, contractors, agents, business partners or distributors on adverse event reporting obligations. • Assist the local Safety team during audits, inspections and other pharmacovigilance interactions with local regulatory authorities; maintain inspection readiness and act as a contact for inspections and internal process audits within the role’s remit. • Contribute to resolution of local safety issues, including CAPAs and related activities, and support quality assurance measures that maintain compliant local operations. • Assist in establishing, reviewing and revising pharmacovigilance and other relevant agreements with partners, contractors, vendors and distributors, as applicable. • Facilitate exchange of adverse event information with service providers, distributors and business partners in line with applicable agreements and procedures; support local safety literature screening. • Where assigned, review local interventional and non-interventional study protocols, independently sponsored studies, market research plans, patient support programme, sponsored websites and social media projects to help ensure appropriate safety monitoring, reporting, contract language and data collection. • Develop expertise in assigned products or product classes and maintain awareness of current product information, investigator brochures and risk management plans. • Escalate product safety issues to the Safety Country Lead and, when requested, contribute to local medical discussions, responses to safety questions and safety training for internal teams and relevant external partners. • Support local implementation of risk minimization activities and build awareness of product safety issues in the local market and clinical research environment; provide stakeholder feedback as requested. •Participate in global, regional and country safety meetings and contribute to Safety or cross-functional initiatives and the sharing of best practices. •Undertake activities delegated by the QPPV as described in the Pharmacovigilance System Master File, and perform other duties related to the position as defined in applicable SOPs or requested by the supervisor. Basic Qualifications •Master’s degree; or bachelor’s degree and 2 years of directly related experience. •Good working knowledge of company policies, procedures and systems, and a practical understanding of legislation applicable to local safety practices. •Computer literacy, including competent use of databases and safety systems; understanding of relevant medical and safety terminology. •Knowledge of local data privacy requirements and the ability to identify, priorities and escalate safety issues. •Problem-solving ability and confidence in handling core operational safety activities after appropriate training. •Valid certificate of Pharmacovigilance Officer Training issued by the Turkish Medicines and Medical Devices Agency (TİTCK), Ministry of Health of Türkiye. Preferred Qualifications •Professional qualification as a healthcare professional, such as doctor, pharmacist, nurse or veterinarian, or a doctoral degree. •Experience in the biotechnology or pharmaceutical industry, a clinical role or a regulatory agency. .