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Pharmacovigilance Scientist
Oruka Therapeutics. Collect, review, and analyze adverse event reports from clinical trials to identify potential safety signals .
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Collect, review, and analyze adverse event reports from clinical trials to identify potential safety signals
- Support quality control review of individual case safety reports (ICSRs)
- Assist with ongoing safety monitoring, data reconciliation, and quality checks
- Support safety data management, including case processing, follow-up, and adverse event coding
- Assess clinical safety data and document adverse events and emerging safety concerns
- Contribute to risk-benefit analyses and risk mitigation strategies
- Prepare and review DSURs, dRMPs, clinical trial protocol sections, investigator brochures, and regulatory submissions
- Conduct literature reviews and safety signal assessments
- Collaborate with clinical operations, regulatory affairs, medical affairs, data management, bioinformatics, and project management teams
- Support pharmacovigilance and CRO vendor communication and oversight
- Support project management of aggregate reports, safety team meetings, and signal evaluations
- Work with the Senior Medical Director, Pharmacovigilance and Safety, to execute pharmacovigilance strategies
Requirements
What you’ll need- Advanced degree in life sciences (e.g., PharmD, PhD) or related field
- Minimum of 3 years of experience within the pharmaceutical industry, ideally including drug safety experience
- Knowledge of good pharmacovigilance practices, drug safety regulations, and clinical trial processes
- Understanding of pharmacovigilance regulatory practices including CIOMS, EMA, ICH and FDA guidelines
- Experience with adverse event data review, safety signal detection, and safety database management (e.g. Argus, MedDRA, Veeva Vault)
- Strong analytical, communication and presentation skills
- Strong organizational and project management skills
- Ability to collaborate effectively across multidisciplinary teams in a fast-paced environment
Benefits
Comp & perks- Competitive base salary
- Equity
- Performance-related bonus opportunity
- Competitive benefits package
- Supportive and inclusive team environment
- Opportunities for professional growth and development
- Vibrant startup culture with opportunity to impact bringing new medicines to patients