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Medical Safety Professional
4 days ago
Overview
The Pharmacovigilance Specialist plays a critical role in ensuring the safety of patients and clients worldwide. As part of our team, you will collaborate with cross-functional teams to analyze and report on adverse events, supporting our clients' clinical research.
About the Role
- Analyze and process adverse event data to ensure accurate and timely reporting to health authorities.
- Prepare and submit high-quality safety reports, adhering to regulatory guidelines and standards.
- Maintain data integrity and promote compliance with Good Documentation Practice (GDP) standards.
- Develop and implement process improvements to enhance efficiency and reduce manual data retrieval.
- Stay up-to-date with industry trends and regulatory changes, applying knowledge to drive business growth and mitigate risks.
- Analyze stakeholder complaints related to safety reporting, addressing concerns in real-time and collaborating with project managers and clients to implement effective solutions.
Requirements
- Bachelor's or Doctoral degree in Pharmacy, Medicine, or related field.
- 2-3 years of experience in drug safety, preferably with knowledge of Good Clinical Practice (GCP), GDP, and International Conference on Harmonization (ICH) guidelines.
- Strong analytical and problem-solving skills, with excellent written and oral communication abilities.
- Proficiency in Microsoft Office and scientific databases such as PubMed and Embase.
- Ability to work effectively in a collaborative team environment and adapt to changing priorities.
Desired Qualifications
- Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding.
- Experience working with Word, PowerPoint, Excel, Outlook, EndNote, and scientific databases.
- Background in drug development or clinical trials.
Estimated Salary Range: $80,000 - $110,000 per annum
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