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About the role
Key responsibilities & impact- Accountable for safety across the study
- Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level
- Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP)
- Performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead
- Monitor study safety issues and provide input to serious adverse events (SAEs) reports
- Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context required for benefit-risk assessments
- Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications
- Communicates safety information to sites across the study and provides responses to questions on safety
- Provide medical input during development and updates to the clinical development plan
- Designs clinical studies to meet the stated objectives
- Ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and have been reviewed by IRB/IECs
- Provides medical input into country feasibility
Requirements
What you’ll need- Medical degree (M.D./D.O. or equivalent)
- 4+ years’ work experience
- Licensed by a health authority to prescribe medicines (independent of supervision) for at least two years (post "intern/houseman" year) and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year
- Possesses the ability to critically evaluate medical/scientific information
- Understands the design, development, and execution of clinical programs and studies
- Documented experience in the pharmaceutical industry related to clinical research programs and registration activities
- Responsible for managing multiple studies
Benefits
Comp & perks- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical degreeclinical researchsafety surveillancerisk assessmentbenefit-risk assessmentclinical study designregulatory complianceadverse event reportingdata reviewmedical input
Soft Skills
communicationcritical evaluationteam collaborationproblem-solvingorganizational skillsattention to detaildecision-makinginterpersonal skillsadaptabilityleadership
Certifications
M.D.D.O.licensed to prescribe medicines
