Pharmacovigilance Manager | Integrated Commercial Solutions (ICS)

Overview

Pharmacovigilance Manager | Integrated Commercial Solutions (ICS) Jobs in Nairobi County, Kenya at DP World

Title: Pharmacovigilance Manager | Integrated Commercial Solutions (ICS)

Company: DP World

Location: Nairobi County, Kenya

Job Context

• Lead and maintain a compliant Pharmacovigilance system across African markets
• Ensure patient safety, regulatory compliance, quality oversight and timely reporting of adverse events
• Operational lead for PV activities, supports QPPVs/ Local PV responsible in fulfilling obligations
• Ensures compliance with local regulations, company procedures and Good Pharmacovigilance
• Practice (GVP)

Key Performance Areas (KPAs)

• Pharmacovigilance system management; manage & maintain regional PV system, ensure compliance with local legislation, GVP guidelines, and company procedures, maintain PSMF (where applicable), continued inspection readiness
• Case management; timely receipt, triage, review and reporting of ADRs, SAEs, PQC with safety implication, Special situation reports, monitor local and global reporting timelines, oversee reconciliation of safety cases with partners and sub distributors
• Risk Management; Coordinate implementation of RMPs, support preparation and submission of PSUR/PBRER, DSUR, Line listings, HA safety responses, monitor safety signals and recommend appropriate actions
• Regulatory Compliance; timely submission of all PV documentation required by NRA, Primary operational contact during inspections, support responses to regulatory safety queries and maintain compliance tracker for African markets
• Quality Management; Develop and maintain PV SOPs, Internal PV compliance reviews, Manage CAPAs, Monitor KPIs and quality metrics
• Vendor & Partner Oversight; Oversee PVAs, assist in qualification and monitoring of distributors, third party services and local safety partners, Contractual compliance to PV obligations
• Training; Develop & deliver annual PV training programmes and ensure completion, including third parties where applicable, maintain training records and competency assessment
• Collaborate with Regulatory, Medical, Commercial, Quality Assurance, Supply Chain and marketing to ensure patient safety considerations are integrated into all business activities

Qualifications Required

• Bachelor of Pharmacy, registered Pharmacist
• Post graduate qualification in Pharmacovigilance, Drug Safety (advantage

Skills and Experience Required

• Minimum 2-5 years of pharmaceutical industry, experience managing PV systems across African regulatory systems
• Experience in PV Health Authority inspections, PV database and electronic safety reporting, development of SOPs and QMS
• Competency in Good Pharmacovigilance practice and global pharmacovigilance requirements including ICH and WHO guidance
• Strong leadership, accountability, organizational & analytical skills and aptitude for details
• Sound judgment and strong communication skills while managing multiple priorities across countries

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.

With a dedicated, diverse and professional team of more than 111,000 employees from 159 nationalities, spanning 77 countries on six continents, DP World is pushing trade further and faster towards a seamless supply chain that’s fit for the future.

We’re rapidly transforming and integrating our businesses – Ports and Terminals, Marine Services, Logistics and Technology – and uniting our global infrastructure with local expertise to create stronger, more efficient end-to-end supply chain solutions that can change the way the world trades.

What’s more, we’re reshaping the future by investing in innovation. From intelligent delivery systems to automated warehouse stacking, we’re at the cutting edge of disruptive technology, pushing the sector towards better ways to trade, minimising disruptions from the factory floor to the customer’s door.

DP World is on a mission to transcend boundaries and bridge the gap between all nations and cultures – not just in what we do but also in how we behave.

We are dedicated to creating a culture where everyone feels respected, supported, and empowered to reach their full potential. We believe that embracing inclusion and diversity, drives innovation and growth and helps us connect people, businesses, and societies. Free minds and different perspectives are changing our world, and together we can change what’s possible.

WE MAKE TRADE FLOW TO CHANGE WHAT’S POSSIBLE FOR EVERYONE.

EEO Statement

DP World is committed to the principles of Equal Employment Opportunity (EEO). We strongly believe that employing a diverse workforce is central to our success and we make recruiting decisions based on your experience and skills. We welcome applications from all members of society irrespective of age, gender, disability, race, religion, or belief.

By submitting your resume and application information, you authorize DP World to transmit and store your information in the world-wide recruitment database, and to circulate that information as necessary for the purpose of evaluating your qualifications for this or other job vacancies.