Local Medical Safety Specialist

• 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.

• 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.

• 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.

• By preference a minimum of 2+ years pharmaceutical industry experience in a product vigilance responsibility role

Vacancies in Turkey