Job Title: Local Person for Pharmacovigilance (LPPV)/ Pharmacovigilance Specialist.
Job Location: Sana’a- Yemen
Number of Positions: 1
Job Duration: Open contract
Deadline: Dec-29, 2022

About The Company 

The company is a leading Pharmaceutical company in the field of selling and distributing pharmaceuticals, and medical appliances in Yemen. It represents nearly 23 international companies in the field of pharmaceutical and medical appliances. The Company emphasizes extensively the importance of providing highly-qualified human staff for managing the company and selecting qualified, efficient, and gifted personnel with wide experience in the field of management.

Job Description

A Pharmacovigilance Specialist will manage the Pharmacovigilance activities through follow-up call intake, documentation, and urgent responses to all PV correspondences from national authorities and business partners. He will be able to prepare all needed SOPs and policies related to PV activities and complete the PV audit. He will perform processing of adverse events, conduct follow-up, and write accurate and complete documents in accordance with internal guidelines, SOPs, EU, and EMA safety regulations. He will maintain distinctive quality and commitment as the operating philosophy in carrying out all processes and continually seek out ways to enhance the PV experience with both national authorities and business partners.

Essential Tasks and Responsibilities

• Establish the Pharmacovigilance system and monitor its performance and improvement using KPIs.
• Oversee the Pharmacovigilance processes and activities. 
• Prepare SOPs, Plans, and Policies related to PV activities.
• Prepare the Pharmacovigilance reports. 
• Develop training materials and perform the Pharmacovigilance training for the company’s staff, and customers when needed.
• Revise the PV agreements and ensure their suitability with local laws and legislation.
• Report adverse events to the Regulatory Authorities and the Manufacturers according to regulations, SOPs, and related PV agreements.
• Follow up on the PV cases when more information is needed.
• Maintain a log, compliance information, and filing system for all Pharmacovigilance cases.
• Comply with the PV Agreements.
• Perform PV regulatory intelligence.
• Act as the single contact point on a 24/7 basis.
• Provide Health Authorities with any information relevant to product safety after communicating with the manufacturer as per PV agreements.
• Perform the PV screening of the local medical literature and inbound communication channels for reviewing any safety information and any emerging safety concerns.
• Ensure the conduct of Pharmacovigilance and submission of all Pharmacovigilance-related documents in accordance with the national legal requirements and as per the PV agreements.
• Receive and initially process product complaints; forward information to the Quality Assurance Manager and the manufacturers.
• Provide information relevant to the benefit-risk evaluation to the national authorities in compliance with partners and PV agreements.
• Document and archive all documents electronically and physically in a safe appropriate manner.

Job Competencies

Education and Experience Requirements

• Bachelor's degree in Pharmacy or Medicines as a minimum.
• Certification in Pharmacovigilance training.
• At least 2 years of experience in Pharmacovigilance.
• Knowledge of PV guidance
• Experience in SOP formulation.

Necessary Skills and Abilities

• Proficient computer knowledge.
• Strong verbal, written, and interpersonal communication skills.
• Strong organization and prioritization skills; ability to multitask.
• Strong decision-making skills.
• Strong problem-solving skills.
• Ability to work independently and collaboratively in a multidisciplinary team.
• Flexibility to adapt and meet fluctuating business priorities.
• Ability to occasionally work extended and/or flexible schedules to meet partners' requirements.