ROLE OVERVIEW:
As a Senior Manager of Pharmacovigilance (PV) Compliance you will coordinate PV global compliance strategies and ensure readiness of the PV system to audits and inspections. You will perform quality review of the activities, processes, and deliverables of the PV department, manage deviations and addressing CAPAs. You will maintain the SOPs and PV procedures UpToDate and manage drug safety team training activities in collaboration with Quality assurance team. You will interact with multiple Global Drug Safety functions and other interface functions on a global basis to ensure implementation strategy of required changes to the PV system is aligned across different functions.
WHAT YOU CAN EXPECT TO DO IN THE ROLE:
Reporting to the Senior Director, Pharmacovigilance, you will:
- Collect and communicate metrics data as related to the ongoing assessment of pharmacovigilance quality, consistency, and operational effectiveness. Manage deviations tracking and root analysis, ensure compliance improvement of the PV system, appropriate control of timely safety reporting and risk management activities.
- Contribute to audit planning, coordinate preparation and conducting of audits and inspections. Prepare Pharmacovigilance Corrective Action/Preventive Action CAPA Plan and manage addressing possible observations.
- Maintain PV related procedures and SOPs UpToDate and monitor compliance with training requirements in collaboration with Quality Assurance team.
- Maintain communication with QPPV, oversee global PSMF management and preparation of aggregate safety reports in line with international regulations, guidelines, and internal standards.
FOR THIS ROLE YOU WILL NEED:
- Bachelor’s degree in pharmacy, nursing, life sciences or equivalent. Advanced Degree is preferred.
- Previous experience in PV quality control and/or quality assurance in the pharma industry. We prefer this experience to be at least 5 years.
- Previous Experience with regulatory inspections and pharmacovigilance system audits.
- Previous experience in pharmacovigilance compliance, knowledge of drug safety reporting, safety risk management activities and procedures development obtained in global pharmaceutical company or CRO.
- Current knowledge of global guidance documents and regulatory requirements as applied to clinical trial and post-marketing adverse event reporting and safety risk management.
- Knowledge of drug safety databases (preferably ARISg).
- Knowledge of MedDRA and WhoDrug coding principles and practical applications.
- Hands on experience/understanding in end-to-end case processing.
- Professional level in English, both in oral and written communications
- Distinct sense of regulatory compliance
About Covis:
Founded in 2011, Covis Pharma is a private equity backed global specialty pharmaceutical company that markets therapeutic solutions in 50+ countries, for patients with life-threatening conditions and chronic illnesses. Our paramount concern is patient outcomes as we focus on improving the health of people with serious medical conditions. Apollo Global Management is the private equity sponsor of Covis Pharma.
If you are looking to be a part of a global, vibrant, and fast-growing organization, have a positive attitude, seeking career development and acceleration and are energized by being a part of improving the lives of the patient’s we serve, we are the perfect match for you.
Our offer to you:
By joining Covis Pharma you will be a part of a dynamic and energized team with a vested interest in your personal and professional development. You will be able to provide input into impactful decisions and be a part of shaping our company’s future. The skills and business insight you gain will serve as an invaluable foundation toward developing your career with us. We offer opportunities for advancement and support this through multiple development channels.
Our inclusive company culture brings unique perspectives and embraces diversity of thought. We actively seek to hire and develop the best and brightest team members from all backgrounds, ensuring our continued success into the future.
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!
Get to know us:
Find out more about Covis Pharma by visiting www.covispharma.com
Find out more about Apollo Global Management by visiting www.apollo.com
