Pharmacovigilance Associate

4 days ago

Delhi Delhi, India Rx Connections Full time

**Job Title**: Pharmacovigilance Associate

**Position Type**: Full-Time

**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

**Job Types**: Full-time, Permanent

Pay: ₹30,000.00 - ₹60,000.00 per month

**Experience**:

- pharmacovigilance: 2 years (required)

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