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Safety Physician
Syneos Health. Perform medical review of adverse events for investigational and marketed products .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates medical expertise in pharmacovigilance and safety review, with a strong ability to perform medical review and interpretation of adverse event cases and aggregate safety reports. Proficient in regulatory compliance and mentoring internal safety staff.
Highest-signal resume keywords
Medical ExpertisePharmacovigilance ExperienceRegulatory Compliance KnowledgeMedDRA FamiliaritySafety Database Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical ReviewAdverse Event Case AssessmentAggregate Safety Report InterpretationSafety Issue ManagementRegulatory Compliance
Soft Skills
CommunicationMentoringTraining
Tools & Technologies
ARGUSWHO-DRL
Industry Keywords
PharmacovigilanceSafety InformationSOP ComplianceClinical DevelopmentPost-Marketing Safety
About the role
Key responsibilities & impact- Perform medical review of adverse events for investigational and marketed products
- Apply medical interpretation and consistency to adverse event case assessment with Safety and Pharmacovigilance colleagues
- Ensure regulatory and SOP compliance for evaluation, reporting, and surveillance of safety information
- Identify, communicate, and manage potential safety issues
- Interact with client safety and medical personnel
- Stay current on clinical and drug development information relevant to contracted programs
- Provide medical review and interpretation for aggregate safety reports, including annual safety reports, PSURs, and PADERs
- Maintain medical and pharmacovigilance expertise through continued medical education
- Mentor and train internal safety staff, including case processing staff
- Perform activities in compliance with corporate and departmental policies, SOPs, work instructions, and project-specific operating guidelines
- Perform other duties assigned by management
Requirements
What you’ll need- Medical expertise and experience in pharmacovigilance and safety review
- Familiarity with MedDRA
- Familiarity with WHO-DRL
- Familiarity with safety databases such as ARGUS
- Knowledge of regulatory and SOP compliance for clinical and post-marketing safety information
- Ability to perform medical review and interpretation of adverse event cases and aggregate safety reports
- Ability to identify, communicate, and manage potential safety issues
- Ability to interact with client safety/medical personnel
- Ability to mentor and train internal safety staff
- Equivalent experience, skills, and/or education will also be considered
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Continued medical education opportunities