Job Summary:
As a Pharmacovigilance Business Analyst, you will play a pivotal role in driving the success of our organization by ensuring the safe and effective use of medicines.
Key Responsibilities:
* Collect and analyze requirements for pharmacovigilance systems and workflows to identify areas of improvement.
* Collaborate with cross-functional teams including business users, regulatory experts, and IT professionals to design and implement safety systems.
* Develop comprehensive documentation of business processes, data flows, and system functionalities related to adverse event reporting.
* Ensure compliance with global regulatory standards and guidelines.
* Provide support and training to end-users on safety systems and processes.
Qualifications:
* Bachelor's degree in a relevant field such as life sciences, pharmacy, or public health.
* Advanced knowledge of pharmacovigilance principles and regulatory requirements.
* Experience working with safety systems such as Argus, ArisG, Veeva Vault Safety, and other PV systems.
* Strong analytical and problem-solving skills with attention to detail.
* Excellent communication and interpersonal abilities to work effectively with diverse stakeholders.
Desirable Skills: Certification in pharmacovigilance, experience with validation and user acceptance testing of PV systems, and proficiency in relevant software applications.
What We Offer: A dynamic work environment, opportunities for professional growth and development, and a competitive compensation package.