Medical Reviewer

6 days ago

Bengaluru Karnataka, India Nexinfra Solutions Full time

As a Medical Reviewer in Pharmacovigilance, you will play a crucial role in evaluating and assessing the safety of pharmaceutical products. Your primary responsibilities will include reviewing and analyzing adverse event reports, medical literature, and other safety-related information to ensure compliance with regulatory requirements and to contribute to the ongoing safety monitoring of products.
- Evaluate adverse event reports submitted by healthcare professionals, consumers, and other sources.
- Assess the medical and clinical aspects of reported cases to determine causality, seriousness, and expectedness.
- Monitor and review relevant medical literature for safety information related to assigned products.
- Summarize and interpret scientific data to contribute to the safety profile of the products.
- Participate in signal detection activities to identify potential safety concerns or emerging trends.
- Collaborate with cross-functional teams to evaluate and prioritize signals for further investigation.
- Enter and update safety information in the pharmacovigilance database.
- Ensure accurate and timely documentation of all relevant safety data.
- Stay informed about global regulatory requirements related to pharmacovigilance.
- Ensure compliance with regulatory guidelines and standards in safety assessment activities.
- Work closely with other pharmacovigilance team members, regulatory affairs, clinical development, and other relevant departments.
- Communicate safety findings and recommendations effectively within the organization.
- Contribute to the preparation of periodic safety reports (e.g., Periodic Safety Update Reports, Development Safety Update Reports) for regulatory submissions.
- Support risk management activities, including the development and implementation of risk minimization strategies.

Qualifications:

- Minimum qualification: Graduate in Medicine; preference for MBBS & MD in pharmacology or MBBS & MD in other clinical/paraclinical areas with relevant clinical patient management/clinical research experience.
- Preferred experience: 2+ years as a Medical Reviewer.
- Excellent understanding of medical terminology and clinical trial activities, ICH GCP guidelines.
- Proficient in both written and spoken English.

Schedule:

- Day shift

**Experience**:

- total work: 2 years (preferred)

Ability to Commute:

- Banglore, Karnataka (required)

Ability to Relocate:

- Banglore, Karnataka: Relocate before starting work (required)

Work Location: In person

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