This role focuses on supporting drug safety management and medical monitoring activities, ensuring compliance with regulatory frameworks and internal Standard Operating Procedures (SOPs). The company is committed to excellence in pharmacovigilance and offers a collaborative work environment where technical expertise and healthcare knowledge intersect.
Responsibilities in the Job
As a Drug Safety Associate, you will play a critical role in both clinical trial and post-marketing safety activities. Key responsibilities include:
- Power BI Reporting & Data Integration: Design, develop, and maintain Power BI dashboards using SQL, SharePoint, and Veeva Vault RIM data extracts.
- Regulatory Data Management: Manage regulatory information for medicinal products, vaccines, devices, and nutraceuticals by entering data into Veeva Vault.
- Compliance Management: Ensure timely reporting of adverse events to comply with global regulatory obligations.
- Support Safety Projects: Assist in the setup of safety databases, develop entry guidelines, and conduct user acceptance testing.
- Collaboration and Reporting: Participate in client meetings, support physicians in medical monitoring, and provide feedback on investigative site performance.
- Regulatory Submissions: Assist in expedited reporting procedures, register with authorities, and manage submissions via ISIS (International Safety Information System).
- Audits & Inspections: Prepare for and follow up on audits and inspections as needed.
- Training and Development: Attend internal and project-specific safety training sessions to keep skills up to date.
Qualification Requirements
To excel in this role, you will need the following qualifications:
- A degree in Pharmacy, Nursing, Life Science, or a health-related field.
- Alternatively, an Associate’s degree with relevant work experience.
- Healthcare experience in drug safety or related fields is advantageous.
Required Skills
- Proficiency in Power BI tools such as Power Query, DAX, and Power BI Service (minimum 2 years of experience).
- Expertise in Veeva Vault RIM for regulatory information management with at least 2 years of hands-on experience.
- Strong SQL query skills for data extraction and reporting purposes.
- Knowledge of global regulatory reporting requirements.
- Analytical thinking and problem-solving abilities with an eye for detail.
- Excellent communication and interpersonal skills.
- Flexibility and ability to handle multiple tasks efficiently in a dynamic, matrix work environment.