As a Safety Science Coordinator II, you will play a critical role in the safety reporting process. Your responsibilities will include:
- Receiving and identifying suspected Adverse Drug Reactions (ADR) and Adverse Device Events (ADE) reports from various sources such as mail, telephone, fax, email, client employees, and published literature.
- Performing duplicate checks, verifying key dates, and recording them in compliance with client requirements.
- Acknowledging the receipt of ADR/ADE reports via email, fax, telephone, or mail.
- Creating new case entries in the safety database following client SOPs/WIs for valid cases.
- Documenting relevant information in compliance with client requirements.
- Reconciling data from multiple sources, including literature searches and citation reviews.
- Completing data entry and medical coding of all available information in the safety database.
- Initiating follow-up with reporters as per client SOPs/WIs.
- Compiling case narratives according to Client Narrative Composition Guidelines.
- Reviewing safety reports to ensure accurate data entry.
Qualifications
- Proficiency in data entry and medical coding.
- Strong attention to detail and ability to comply with regulatory and client requirements.
- Effective communication skills for follow-ups and acknowledgments.