ProPharma has been a leader in advancing health and wellness for over 20 years. As the world’s largest Research Consulting Organization (RCO), ProPharma partners with biotech, medical device, and pharmaceutical organizations to drive scientific breakthroughs and introduce new therapies. With an end-to-end suite of services, including regulatory sciences, clinical research solutions, pharmacovigilance, and quality compliance, ProPharma ensures the success of its clients throughout the product lifecycle.
Responsibilities in the Job
As a Pharmacovigilance Specialist at ProPharma, you will be instrumental in ensuring patient safety and regulatory compliance. Your key responsibilities include:
- Processing adverse event cases for clinical trials and post-marketed products, including MedDRA coding and assessing case seriousness and expectedness.
- Conducting follow-up activities to gather critical case information.
- Creating and reviewing case narratives for completeness and accuracy.
- Notifying clients as required for case management.
- Developing and delivering training materials for team development.
- Highlighting areas of concern or discrepancies in case management to senior specialists or managers.
- Staying updated on global safety regulations for medicines.
- Performing peer reviews of cases to ensure quality and consistency.
Qualifications
To qualify for this role, you must meet the following educational and professional criteria:
- Required: Bachelor’s degree in Life Sciences.
- Preferred: Advanced degree such as RN, RPh, PharmD, or equivalent qualifications.
- At least two years of related work experience in pharmacovigilance or a related field.
Skills Required
Success in this role requires a strong skill set, including:
- Exceptional verbal, written, and interpersonal communication skills.
- High attention to detail and accuracy in processing cases.
- Strong problem-solving abilities to address issues promptly.
- Ability to work both independently and collaboratively within a multidisciplinary team.
- Excellent organizational and multitasking skills.
- Basic knowledge of pharmacovigilance principles and practices.
