Regulatory Affairs and Pharmacovigilance Pharmacist

Regulatory Affairs and Pharmacovigilance Pharmacist | Imperial Managed Solutions East Africa

DP World

Job descriptions & requirements
Job Context
To ensure business compliance with the relevant regulations as Pharmacist and ensure that the operational tasks are performed as described in the relevant business procedures.
Key Performance Areas (KPAs)
Standard Operating Procedures (SOPS)
• Initiate, implement, review and update SOPs and Process flows to reflect the current regulatory
• requirements and business practices.
• Review all SOPs for regulatory compliance.
• Review QMS Index. Identify business processes (SOPs, Work Instructions and Forms) that requires
• review and ensure review is completed within the approved timeframe and in line within country regulations.
Regulatory Affairs
• Apply for import (Commercial, Clinical Trials samples, medical devices, Promotional Materials
• Registration samples and Prescription) and export permits from the Pharmacy and Poisons Board.
• Apply for Dangerous Drugs authorization permits from the Pharmacy and Poisons Board.
• Compile and submit relevant quarterly reports for DDAs to the Pharmacy & Poisons Board.
• Maintain Product registration status by supporting the department with product renewals to ensure they are done on time and notifications to changes on already registered products done in a timely manner.
• Assist with applications for Approval of advertising materials ensuring that they are in line with legal advertising requirements
• Provide feedback to clients on changes in regulatory requirements and or new requirements.
• Support the department with applications for GMP compliance of product manufacturing sites.
• Ensure that applications for new product registration i.e (Pharmaceutical, Medical Devices, Food Supplements, Herbal and Borderline) are done in time
• Submit notification letters to PPB for both clients and company on any changes relating to product or process.
• Ensure that approvals for all applications submitted are secured in time.
Pharmacovigilance
• Act as the Qualified Person for Pharmacovigilance and back up QPPV as appointed by other clients and coordinate reporting of adverse events received from customers and report them to clients and PPB. Management of safety database and awareness of risk management plans
• Providing 24 hours availability.
• Ensuring individual case safety reports (ICSRs) and periodic safety update reports (PSURs) compliance.
• Ensuring adherence to local regulations, providing prompt information to regulatory authority requests
Reporting
• Update and/or notify the imperial Senior Management and Clients on problems such as regulatory and PV non compliance, Product quality complaints.
• Reply on Audit reports from Imperial QA/Clients
• Communicate with Clients on various matters that pertain to their business - assist with query investigation
Non-Conformances
• Initiate / ensure that non-conformances are initiated, reviewed, evaluated and closed
Management and Control
• Implement systems for effective control of regulatory compliance.
• Monitor and ensure pharmaceutical compliance to establish depth and management of team through induction training and development of staff.
• Induct new Clients into the QMS via project management, with respect to Regulatory/Product compliance.
Audits and CAPA’s
• Participate in Self inspections, internal and external audits. Conduct self-inspections for relevant areas
Staff and Training
• Recommend training needs to improve Regulatory knowledge and expertise of employees. Conduct relevant training to staff members. ·
• Ensure individual training records are up to date
Agreements
• Review PV and Regulatory agreements for all vendors, holders of certificates of registration and 3rd Party Service providers where services rendered directly affects product quality and patient safety.
Documentation
• Ensure all documentation handled and needed for official records is always filed and easily retrievable.
Maintenance of environmental management system
• Participate in the implementation of departmental and site EMS objectives.
Qualifications Required
• Bachelor of Pharmacy
• Registered with the Pharmacy and Poisons Board
Skills and Experience Required
• Minimum 1 year working experience as QPPV
• Hands on experience with minimum 3 years working in a busy pharmaceutical manufacturing company or pharmaceutical distributor with excellent knowledge of regulatory affairs and pharmacovigilance
• Working knowledge of the CAP 244 and Pharmacy rules
• Team leader with experience in managing and supervising a team.
• Excellent skills in decision–making, problem-solving, creativity, analytical skills, attention to detail
• Planning, project management and organization skills, good communication and ability to interact at a high level with cli Ability to work under pressure
About DP World
Trade is the lifeblood of the global economy, creating opportunities and improving the quality of life for people around the world. DP World exists to make the world’s trade flow better, changing what’s possible for the customers and communities we serve globally.