Pharmcovigilance Specialist at Clintec

Job description

Clinical Pharmacovigilance Specialist (All Levels) - Home-Based in any location across North or South Africa - Permanent Contract!

Clintec International is actively recruiting for Clinical Pharmacovigilance (PvG) Specialists to join our expanding global company. This is a permanent contract, home based opportunity. By working for Clintec, you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Role Description

The Pharmacovigilance Specialist will be responsible for case management activities for Post-Marketing and Investigational Products across their country/territory in accordance with PvG processes and regulations, company policies and procedures. The Pharmacovigilance Specialist will work independently to process Adverse Events.

Responsibilities Of The Clinical Pharmacovigilance Specialist

• Conduct reconciliation of (serious) adverse event reports received
• Translate and process spontaneous and solicited / clinical trial adverse event reports across their country/territory and enter them into the Global Safety database or forward to a designated data entry centre
• Conduct follow-up as requested
• Signal detection and authoring signal work-up documents
• Working closely with the drug safety physician
• Authoring aggregate safety reports (PSURs, PBRERs, DSURs), CCDS sections and RMPs
• Responding to regulatory agencies in relation to safety enquiries
• Reviews global literature for identification of ICSRs and potential safety concerns
• Safety review of clinical trial protocols, IBs, CSRs and informed consents
• Experience of developing listedness/expectedness tables in collaboration with the safety physician
• Submit, as applicable, spontaneous and solicited / clinical trial ICSRs from their country/territory to the local Health Authorities
• File, store and archive safety-related data
• Serve as the back-up coverage in absence of the Pharmacovigilance Country Lead to ensure business continuity
• Comply with PvG regulations and Global Safety policies/procedures and when needed propose a corrective action
• Participate in individual case safety report compliance activities and take the necessary corrective actions locally for late reporting within the country/territory
• Assist in the preparation of audits/inspections for their country/territory and participate in the audit if required
• Identify and communicate potential safety issues
• Assist in the delivery of training to PvG staff and customer-facing non PvG staff (e.g. Sales Representatives, Medical Information etc.)
• Complete and document required PvG training within specified timelines
• Perform ad-hoc activities as requested by the Pharmacovigilance Country Lead

Essential Criteria

• Bachelor’s degree, equivalent or higher qualification, within Medicine, Biological Science, Pharmacy, Pharmacology, Nursing or a relevant Life Science discipline, with equivalent work experience
• Clear understanding of the drug development process
• Proven track record of adherence to ICH-GCP and applicable local regulatory requirements
• Awareness of Pharmacovigilance systems and global requirements within the pharmaceutical industry
• Attention to detail
• Ability to navigate complex projects and interact in a matrix environment
• Work experience within a CRO or Pharmaceutical company, in a similar role
• Excellent communication and presentation skills including the ability to present complex information to both clinical and non-clinical disciplines
• Ability to plan and prioritize workload effectively
• Fluency in English language (both written and spoken)
• Fluency in local language (both written and spoken)
• Confident in interacting with people in the organisationDesirable Criteria
• Experience of assisting QPPV
• Membership of local responsible bodies or international clinical groups
• Ability to mentor, train, supervise and inspire confidence in newcomers to the company and industry