Pharmacovigilance Associate
2 weeks ago
Job Title: Pharmacovigilance Associate
Position Type: Full-Time
Company Overview: Rx Connect Specialty Pharmacy is a leading specialty pharmacy focused on providing high-quality medications and support services to patients with complex, chronic, and rare conditions. We are dedicated to patient safety, compliance, and excellence in pharmacy
Position Summary: The Pharmacovigilance Specialist will play a crucial role in ensuring patient safety by overseeing pharmacovigilance activities, monitoring drug safety profiles, and managing adverse event reporting. This position will collaborate with cross-functional teams to enhance safety protocols and regulatory compliance across our specialty pharmacy services.
Key Responsibilities:
- Monitor, evaluate, and report adverse events and potential drug interactions as per regulatory requirements
- Collect, assess, and document pharmacovigilance data from patients, healthcare providers, and other stakeholders
- Perform root cause analyses to identify and address safety issues, ensuring high standards of patient safety
- Prepare and submit timely pharmacovigilance reports in compliance with regulatory guidelines
- Collaborate with clinical and compliance teams to ensure seamless reporting and patient follow-up reporting
- Develop, update, and implement pharmacovigilance policies, work instructions, SOPs, and protocols to align with industry regulations
- Conduct risk assessments and contribute to risk management plans to identify and minimize potential safety risks
- Provide regular safety and pharmacovigilance training to staff and support their understanding of pharmacovigilance processes
- Stay updated on regulatory changes required by stakeholders and adapt pharmacovigilance practices to address potential impacts effectively
- Reconcile monthly reports to verify data accuracy, identify discrepancies, and ensure timely submission to regulatory authorities and stakeholders
- Conduct quality assurance activities, including audits and reviews of pharmacovigilance processes, to ensure compliance with regulatory standards and internal protocols
- Perform other relevant duties as assigned
Qualifications:
- Healthcare background, Bachelor's degree in pharmacy, nursing, life sciences, or a related field preferred.
- Minimum 2 years of experience in pharmacovigilance, drug safety, or a related field, preferably in a specialty pharmacy or clinical setting.
- Strong understanding of pharmacovigilance regulations.
- Proficiency in pharmacovigilance databases, reporting tools, and safety information management.
- Knowledge of pharmacological and medical terminology
- Excellent organizational, analytical, and communication skills, with attention to detail.
- Ability to work independently and collaboratively in a fast-paced environment.
- Commitment to patient safety, compliance, and continuous quality improvement.
- Proficiency with Microsoft Office Word, Excel, PowerPoint and Adobe Acrobat, Safety Databases
We offer a competitive salary , as well as opportunities for career advancement within our growing company. If you are passionate about helping patients and thrive in a fast-paced environment, we encourage you to apply for this exciting opportunity.
To apply, please submit your resume at . We thank all applicants for their interest, however, only those selected for an interview will be contacted.
Job Types: Full-time, Permanent
Pay: ₹30, ₹60,000.00 per month
Experience:
- pharmacovigilance: 2 years (Required)
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