Remotely
pharmacovigilancedataregulatorysafetymedicalwritingsignal_evaluationclinicalstudyreportsriskmanagementplan
Job Description
📋 Description
- This role supports product safety profile and benefit-risk across lifecycle.
- Partner with cross-functional teams on signal detection and evaluation.
- Prepare written/verbal summaries for signal management to senior management/regulators.
- Oversee surveillance activities from safety data sources and literature.
- Develop strategies for regulatory safety requests with data from multiple sources.
🎯 Requirements
- Degree in Health Sciences or equivalent with relevant experience.
- Experience with drug development, regulatory safety and post-marketing support.
- Strong communication and multi-project management skills.
- Proficiency in Microsoft Word/Excel and basic project management.
- Ability to work independently in a matrix team environment.
🎁 Benefits
- Comprehensive benefits package including PTO and health insurance.
- Long-term incentive eligibility.
- Equal opportunity employer commitment.