Regulatory Affairs & Pharmacovigilance Manager İş İlanı

QUALIFICATIONS AND JOB DESCRIPTION

Requirements & Qualifications

• Degree in Medicine or Pharmacy sciences,

• Minimum 3 years experience in registration (preferably at least 2 years in managerial position),

• Leadership skills as this position requires has direct report/s,
• Negotiation & communication skills,
• Organization skills and high accuracy in documentation,
• High sense of urgency,
• Knowledge of new decrees & guidelines,
• Multitasker,
• Awareness and adherence to company internal SOPs & compliance standards,
• Promptness in respond to authorities requirements and prompt in deliverables,
• Analytical skills,
• Problem-solving skills,
• Presentation skills.

Key Responsibilities

For Regulatory Affairs

• Develop regulatory strategy and provide regulatory expertise within projects for products under development and/or marketed products,
• Coordinate dossier and briefing package preparations according to the plans (new medicinal product and maintenance) and monitoring dossiers up to implementation,
• Ensures optimal support to key stakeholders to deliver on-time high-quality dossiers in compliance with Health Authority requirements,
• Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate together with department director when necessary,
• Manage the maintenance of a portfolio of products (SPC-PIL variation, CMC variations, Renewals),
• Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of,
• Provide support and communicating information on products to other functions (approvals etc.) and ensure that information is interpreted correctly,
• Review and validate at country level promotional & training materials,
• Involved in activities such as shortages, DHPC, B/R reevaluation, recall etc.
• Coordinate GMP inspection submissions with local QAM,
• Support the consolidation and provision of regulatory expertise and giving input about requirements and needs,
• Follow regulatory changes, competitor’s status and assess the potential impact on daily activities and project strategy,
• Facilitate and deliver the regulatory strategy to support the registration and lifecycle of the asset.

For Pharmacovigilance

• Establish and maintain the Local PV system compliant with local regulations and HQ requirements,
• Ensure local safety data collection and safety reporting,
• Ensure, in Turkey, adequate PV training of Servier Turkey employees and PV related vendors,
• Ensure local processes for monitoring of PV system compliance and quality improvement,
• Support the preparation and the conduct of PV inspections in close cooperation with the global PV department,
• Implementation and maintenance of local procedural documents,
• Compliance with local PV KPIs, which includes ICSRs submissions, Signal Management, periodic reports and EC notifications if applicable,
• Compliance regarding reporting and processing of PV Non-Compliances,
• Ensure safety surveillance tasks including regular interaction and exchange of expertise with other local departments that receive PV information,
• Continuous monitoring of the benefit-risk profile of products under local responsibility,
• Contribution as appropriate at the local level for implementation and monitoring of risk minimization measures for all products.