Due to increased business activity at Phoenix Clinical Research, our Pharmacovigilance department is looking for PV Associates

Candidates profile: Life Sciences/Pharmacy/Dentistry fresh graduates

Job type: full-time permanent employees

Location: remote working – anywhere in Egypt, Lebanon, Jordan, Tunisia, Algeria or UAE

Within the role, you will be responsible for:

• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Reconciliation (clinical, partners)
• Personal data protection
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• MedDRA and WHO coding
• Database Outputs and Reports (including data for monthly reporting to clients)
• Workflow & resource management

Arabic & English proficiency needed

Only SUITABLE candidates can send their CV at: msalama@phoenix-cr.com, with the subject email “Name – PV Associates – Country”

Due to increased business activity at Phoenix Clinical Research, our Pharmacovigilance department is looking for Medical Reviewers

Candidates profile: Medical Doctors fresh graduates

Job type: full-time/part-time employees

Location: remote working – anywhere in Egypt, Lebanon, Jordan, Tunisia, Algeria or UAE

Within the role, you will be responsible for:

• Reviewing and giving medical opinion on various reports originating from literature
• Reviewing literature references for signal detection and aggregate reports
• Writing medical comments
• Contributing to creating search strategies

Arabic & English proficiency needed

Only SUITABLE candidates can send their CV at: msalama@phoenix-cr.com, with the subject email “Name – Medical Reviewers – Country”

Position summary:

• Establish and maintain the  Pharmacovigilance System for the Products (PSMF).
• To have an overview of medicinal product safety profiles and any emerging safety concerns, if possible.
• To maintain awareness of PV regulatory requirements and developments.
• To identify, collect and report adverse events (ADRs, SAEs, SARs, SUSARs).
• To ensure the conduct of PV activities and the submission of all PV-related documents e.g. ICSRs, SUSARs, DSURs, and Risk Management Plans) is in accordance with the legal requirements and Good Pharmacovigilance Practices (GVP).

Requirements

• Pharmacist
• Minimum 1-2 years of experience in Pharmacovigilance / Drug Safety / Medical Information
• Knowledge and familiarity with clinical trials
• Awareness of PV guidelines and regulations in the relevant country
• Residency & Legal Authorization to work in the relevant country
• For Oman: Omani nationals resident in Oman are preferred
• Strong written and verbal communication skills including good command of English

Only FITTING candidates can send their CV on: msalama@phoenix-cr.com, with the subject email “Name – QPPV – Country”

Requirements:

• Bachelor’s degree in a science-related field or equivalent certification/licensure from an appropriately accredited institution
• Minimum 3 years of experience as a CRA in KSA
• Experience in interventional trials
• Fluent in Arabic and in English, both written and verbal
• ICH-GCP Training is a must
• Availability for immediate hiring
• Good Computer Skills

Suitable candidates should already be located in KSA.

Interested candidates shall send their CV on: sghobrial@phoenix-cr.com

Requirements:

• Bachelor’s degree in a science-related field or equivalent certification/licensure from an appropriately accredited institution
• Minimum 3 years of experience as a CRA in Lebanon
• Fluent in Arabic and in English, both written and verbal
• ICH-GCP Training is a must
• Good Computer Skills

Suitable candidates should already be located in Lebanon.

Interested candidates shall send their CV on: sghobrial@phoenix-cr.com

(6-months contract to be renewed)

Job Requirements:

• Based in Egypt.
• Medical Doctor or Pharmacy degree or Masters or any other advanced degrees in medical sciences.
• Minimum 4 years Project Management experience.
• Regional Experience is recommended.
• Fluent in Arabic, English, both written and verbal. French or any other language is a plus.

Job Responsibilities:

• Provide input in developing specific sections of protocol and related documents, feasibility, site selection finalization of monitoring and data management options according to Phoenix CR or the study Sponsor’s SOPs.
• Assume overall responsibility for Ethics committee approval, development of recruitment strategies to increase patient randomization into the trial, the provision of clinical trial materials, and management of the trial.
• Ensures that all aspects of GCP are complied with at all times through the provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
• Implement and follow pre-approved procedures for any deviations.
• Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion.
• Participate in corporate global clinical research teams ensuring that colleagues are updated on all relevant issues.
• Ensure the smooth running of the clinical research department by developing systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
• Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.
• Has responsibility for the financial management of the clinical trial program including budget planning, resource allocation and preparation of quarterly reports.
• Implement training programs for CRAs and other clinical staff with topics that include: principles and practices of project management, team communication, adverse event reporting and the importance of pharmacovigilance, and budget control and reporting.
• Establishes working relationships with client project teams which results in client satisfaction, operational excellence and thereby increases the potential for repeat business.
• Performs other duties as assigned by management like.

Interested candidates can send their CV on: mdakhloul@phoenix-cr.com

Job Requirements:

• Bachelor’s degree in life sciences or related field
• Native speaker or fluent in Arabic
• Fluent in English
• Based in UAE

Job Description:

• Support with subject recruitment efforts
• Monitor research participants to ensure adherence to study protocol
• Ensure that non-serious and serious adverse events are properly documented and reported
• Liaise with laboratories regarding findings and screen all laboratory results when received and follow protocol procedure regarding abnormal results
• Ensure proper filing and maintenance of study documents
• Communicate closely with monitors, Sponsors, and Investigators
• Provide accurate and timely data collection, documentation, entry, and reporting on eCRFs
• Adhere to Good Clinical Practice, study protocols, and local requirements
• Ensure the scientific integrity of data and protecting the rights, safety, and well-being of the enrolled patients
Interested candidates shall send their CV to: mhassan@phoenix-cr.com

Job Requirements:

• Minimum of Bachelor in Pharmacy or any science-related field
• Minimum 2 years of experience as a CRA
• Knowledge of GCP and clinical Trial regulations in Kuwait
• Fluency in Arabic and English

Job Description:

• Participate in the investigator recruitment process: performs initial qualification visits of potential investigators.
• Evaluate the capability of the site to successfully manage and conduct the clinical study, both clinically and technically
• Support site staff by providing the needed documents for the submission packages as per local regulations
• Ensure having all local approvals on study-specific documents before the site is initiated
• Perform all site visits from selection to close-out
• Train site staff on all clinical trial procedures and documents
• Train site staff on the EDC system and verifies site computer system
• Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits
• Perform a validation of source documentation as required by Sponsor and works with the site to resolve queries
• Prepare monitoring reports and letters in a timely manner using approved company /Sponsor forms and reports
• Document accountability, stability and storage conditions of clinical trial materials as required by Sponsor 
• Serve as the primary contact between the Sponsor and the site
• Ensure timely transmission of clinical data with the study site and technical reporting
• Assist with final data review and query resolution through database lock

Interested candidates can send their CVs to mdakhloul@phoenix-cr.com

Job Description:

• Support with subject recruitment efforts
• Monitor research participants to ensure adherence to study protocol
• Ensure that non-serious and serious adverse events are properly documented and reported
• Liaise with laboratories regarding findings and screen all laboratory results when received and follow protocol procedure regarding abnormal results
• Ensure proper filing and maintenance of study documents
• Communicate closely with monitors, Sponsors, and Investigators
• Provide accurate and timely data collection, documentation, entry, and reporting on eCRFs
• Adhere to Good Clinical Practice, study protocols, and local requirements
• Ensure the scientific integrity of data and protecting the rights, safety, and well-being of the enrolled patients

Requirements:

• Bachelor’s degree in life sciences or related field
• Native speaker or fluent in Arabic
• Fluent in English

Interested candidates shall send their CV to: info@phoenix-cr.com