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 https://www.jnj.com **Job Function:** Product Safety **Job Sub** **Function:** Pharmacovigilance **Job Category:** Scientific/Technology **All Job Posting Locations:** TR011 J&J Ertürk Sokak Keçeli Plaza İstanbul **Job Description:** **Johnson & Johnson** is recruiting for **Local Medical Safety Specialist** to be located in **Istanbul, Turkey.** **About Johnson & Johnson** 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 https://www.jnj.com/.  The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance. The employee is part of the Johnson & Johnson Innovative Medicine Office of the Chief Medical Officer (JJIM OCMO). **Essential Job Duties and Responsibilities** + Ensure that the local Pharmacovigilance (PV) system is managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any PV agreements with third party business partners. **Task may include:** + Ensure local collection, review, reporting, reconciliation, and follow up of Individual Case Safety Reports (ICSR). + Ensure implementation of local literature process. + Maintain oversight of corresponding vendor activities as required. + Ensure PV audit/inspection readiness at the LOC level at all times. + Maintain oversight of ICSR inbound and outbound compliance. + Address follow-up actions from Local Safety unit (LSU) owned non conformances, including LSU related CAPAs. + Review, translate (if applicable), prepare, submit and track aggregate reports as required by local regulations and ensure compliance oversight requirements are met. + 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. + Engage in local industry associations and drive local policy shaping initiatives based on One J&J Voice. + Ensure that day-to-day PV activities and safety activities for medicinal and non-medicinal products (i.e., medical devices) 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) + 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). + Support global roll out AE/PQC training in LOC. + Manage AE/PQC training to distributors/vendors and translation of AE/PQC training material, where needed. + Establish Product knowledge with focus on safety profiles + Participate in LMS product teams as applicable. + Conduct the local product compliance related activities in collaboration with stakeholders such as Medical Safety Officers (MSO) as needed. + Communicate new relevant safety information available in a timely manner to GMS and to LOC stakeholders as per procedure. + Involvement in local safety signal detection, if applicable. + Prepare local RMP/Addendums based on internal alignment and local/global procedures as required. + Participate or lead LMS projects and initiatives locally, regionally and globally. + Be an ambassador of the Local Medical Safety mission and vision. **Minimum Qualification** + A bachelor’s degree in medicine or pharmacy is a must. + Proficiency in medical terminology. + Excellent verbal and written communication skills + Fluency in Turkish and English languages are 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. + Excellent computer proficiency e.g. MS Office, + Proven expertise and experience in pharmaceutical regulations and R&D processes is preferred. + Proficiency in global and local Standard Operating Procedures (SOPs) + Must be able to work independently with minimum supervision while meeting tight deadlines. **Experience** + By preference a minimum of 2+ years pharmaceutical industry experience in a product vigilance responsibility role