Company Description: (Business Overview)
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Our mission is to help people live longer, healthier and happier lives. Our Credo defines our responsibilities to: the patients and consumers we serve, our employees, the communities in which we live and work, and to our shareholders. Our citizenship and sustainability practices are an important part of those responsibilities, and we take this work very seriously.
Aim of the job:
Administrator and back-up of responsible person for Pharmacovigilance for Consumer, Consumer Devices, Cosmetics and Pharmaceutical products in J&J.
Manages adverse events:
Accurately evaluates cases for validity and consistency.
Documents cases according to procedures.
Accurately codes product-safety information and product-quality complaints.
Appropriately assesses case severity in order to prioritize follow-up.
Reviews data against source documents.
Submits data in a timely manner.
Properly assesses submission eligibility on a case-by-case basis as per the regulations.
Diligently prepares and checks required documentation.
Identifies appropriate regulatory agency directions and makes case referrals.
Carefully reviews and documents regulatory agency requests.
Prepares responses based on requests.
Working experience with ARGUS Pharmacovigilance system
Files case reports according to appropriate archiving practices.
Contributes to ensure compliance of pharmacovigilance activities:
Provides training to concerned persons based on the training plan.
Effectively manages training documentation.
Verifies data according to information sources prior to undertaking case reconciliation.
Properly reconciles cases and follows up on issues with concerned departments.
Plays an active role in the preparation, conduct, and monitoring of audits and inspections.
Archives documents according to prevailing standards.
- Graduation degree on pharmacy or medicine.
- 1 to 3 years of relevant experience in pharmacovigilance
- Proficiency in medical terminology
- High level knowledge about local pharmacovigilance regulation and guidelines.
- Result oriented personality with strong planning, reporting and analytical skills
- Excellent command of English, both written and spoken is a must for the position
Johnson & Johnson Sihhi Malzeme Ltd. (7347)