Beschreibung
Responsibilities:- Provide support to scope staff handling NIPs by answering questions or providing advice on good NIP practices as defined in laws & regulations, codes and internal guidelines & SOPs
- Ensure timely involvement of line management in case of violation of good NIP practices
- Create and maintain training for good NIP practices, regulations, codes and internal guidelines & SOPs
- Identify the need for creating additional or updating existing SOPs or processes/working guidelines on good NIP practices
- Responsible for tracking of NIPs under their scope of responsibility into NIP database(s)
- Ensure each NIP has a program outline which details the nature of the program and safety data collection and reporting processes
- Proactively reports concerns/issues to the NIP Coordinator Lead to ensure compliance with safety SAE and non-serious AE reporting requirements are met
- Ensure a quality control and reconciliation process is in place for on-going NIPs and conduct a NIP risk assessment at least once a year as per global SOP(s)
- Liaison with the Business Units to ensure a proactive review and assessment of all proposed NIPs.
Requirements:
- Demonstrates initiative and accountability
- Strong organizational and project management skills
- Confident decision maker
- Networking, influencing, and interpersonal skills
- Excellent communication skills, both written and verbal
- Minimum 3 years of experience in the pharmaceutical industry
Are you interested or know someone who is? Don`t hesitate to contact me and I will come back to you as soon as possible.
Für mehr Informationen über Real, besuchen Sie www.realstaffing.com