Job Title: Pharmacovigilance Specialist – Case Processing
Summary:
Are you a detail-oriented professional with a passion for patient safety and a strong background in pharmacovigilance? We are seeking a motivated Pharmacovigilance Specialist to join our dynamic team. In this role, you will be responsible for the comprehensive processing of Individual Case Safety Reports (ICSRs), ensuring accuracy, compliance, and adherence to global safety regulations. If you thrive in a collaborative environment and are eager to contribute to a world-class pharmacovigilance team, we encourage you to apply.
About Us:
We are a global leader empowering biotech, pharmaceutical, and medical device companies throughout the product lifecycle. With over 20 years of experience, we have established ourselves as a trusted partner in shaping the future of drug safety. We pride ourselves on our inclusive, diverse, and supportive workplace culture, offering ample opportunities for career development and growth within a collaborative, innovation-driven environment.
Responsibilities:
As a Pharmacovigilance Specialist, your key responsibilities will include:
- Case Processing: Managing the daily processing of adverse event reports, encompassing both clinical trial and post-marketing data.
- MedDRA Coding: Accurately assigning MedDRA codes to adverse events.
- Safety Assessment: Performing seriousness assessments and determining the expectedness of reported events.
- Narrative Writing: Preparing and reviewing comprehensive case narratives.
- Follow-Up: Conducting follow-up activities to obtain additional safety information.
- Client Communication: Sending timely and accurate client notifications based on specific case management requirements.
- Training Support: Assisting in the creation and delivery of training materials for the pharmacovigilance team.
- Escalation: Promptly escalating any discrepancies or complex issues to senior PV staff and managers.
- Regulatory Compliance: Maintaining a thorough and up-to-date knowledge of global safety regulations and guidelines.
- Peer Review: Conducting peer reviews of cases to ensure accuracy, consistency, and quality.
- Miscellaneous Duties: Handling other pharmacovigilance-related tasks and projects as assigned.
Qualifications:
To be successful in this role, you will need the following qualifications:
Education:
- Required: Bachelor’s degree in Life Sciences.
- Preferred: PharmD, MPharm, RPh, RN, or relevant advanced degree.
Experience:
- Minimum of 2 years of experience in pharmacovigilance or safety case processing.
Skills:
- Communication: Excellent written and verbal communication skills.
- Attention to Detail: Impeccable attention to detail and accuracy.
- Problem-Solving: Strong ability to troubleshoot and resolve issues effectively.
- Organization: Exceptional organizational, time management, and multitasking skills.
- Teamwork: Ability to work independently and collaboratively within a cross-functional team environment.
- Pharmacovigilance Knowledge: Basic understanding of pharmacovigilance principles and regulations.
Benefits of Working with Us:
- Global Leadership: Opportunity to work with a global leader in drug safety.
- Inclusive Culture: A diverse, supportive, and inclusive workplace culture.
- Career Development: Opportunities for career development through training and exposure to advanced pharmacovigilance practices.
- Collaborative Environment: A collaborative and innovation-driven work environment.
- Transparent Application Process: We value your time and effort; every applicant will receive a response.
How to Apply:
If you are passionate about pharmacovigilance and meet the required qualifications, we encourage you to apply. Please submit your resume and cover letter through our online application portal.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.