Sr Associate II, Drug Safety
Biogen
8 days ago
Remote friendly (Cambridge, MA)
United States
Operations
Principle Responsibilities:
- Ensure AE case processing in both Post-Marketing and Clinical Trial settings complies with regulatory requirements and corporate/departmental procedures and data-handling conventions, including vendor (CRO) oversight.
- Monitor Biogen Global Safety Database (GSD) and identify/communicate events of interest to internal stakeholders.
- Continuously monitor the compliance and health of the case processing workflow using monitoring reports.
- Monitor the quality of outsourced AESI case processing; ensure high-quality, clinically appropriate queries are developed and issued.
- Support PML adjudication meetings; present AESI clinical data and document/disseminate key decisions.
- Support team leadership in execution of AESI-related activities, including contributions to regulatory deliverables for PML and internal analyses (e.g., FDA AEMS).
Qualifications:
- Bachelor’s degree in nursing, pharmacy, or other health related profession.
- 2+ years experience in a Drug Safety environment.
- Solid understanding of worldwide Post-Marketing and Clinical Trial Adverse Event Regulations including GCP, CIOMS, EMA GVP.
- Ability to understand, evaluate, and succinctly summarize technical, scientific, and medical information.
- Ability to interpret regulations and apply them to departmental SOPs and guidelines.
- Strong collaboration and communication skills in team and matrix environments.
- Highly organized, adaptable, and able to manage multiple priorities in a fast-paced setting.
- Critical thinker with strong problem-solving abilities; sound judgment in workflow assessment and decision-making.
- Proficient in computer systems and quick to learn new tools/technologies.
Preferences:
- 3+ years experience in a clinical setting.
- Ensure AE case processing in both Post-Marketing and Clinical Trial settings complies with regulatory requirements and corporate/departmental procedures and data-handling conventions, including vendor (CRO) oversight.
- Monitor Biogen Global Safety Database (GSD) and identify/communicate events of interest to internal stakeholders.
- Continuously monitor the compliance and health of the case processing workflow using monitoring reports.
- Monitor the quality of outsourced AESI case processing; ensure high-quality, clinically appropriate queries are developed and issued.
- Support PML adjudication meetings; present AESI clinical data and document/disseminate key decisions.
- Support team leadership in execution of AESI-related activities, including contributions to regulatory deliverables for PML and internal analyses (e.g., FDA AEMS).
Qualifications:
- Bachelor’s degree in nursing, pharmacy, or other health related profession.
- 2+ years experience in a Drug Safety environment.
- Solid understanding of worldwide Post-Marketing and Clinical Trial Adverse Event Regulations including GCP, CIOMS, EMA GVP.
- Ability to understand, evaluate, and succinctly summarize technical, scientific, and medical information.
- Ability to interpret regulations and apply them to departmental SOPs and guidelines.
- Strong collaboration and communication skills in team and matrix environments.
- Highly organized, adaptable, and able to manage multiple priorities in a fast-paced setting.
- Critical thinker with strong problem-solving abilities; sound judgment in workflow assessment and decision-making.
- Proficient in computer systems and quick to learn new tools/technologies.
Preferences:
- 3+ years experience in a clinical setting.