Senior Scientific Director, SERM
GSK
full-time
Posted on:
Location Type: Office
Location: Waltham • Massachusetts • Pennsylvania • United States
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Salary
💰 $217,800 - $363,000 per year
Job Level
About the role
- Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting.
- Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate.
- Makes recommendations for the further characterization, management, and communication of safety risks.
- Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs.
- Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
Requirements
- PhamD/PhD for Scientist (preferred)
- Bachelors of Science in Life Sciences or Medical Sciences (minimum standard)
- 10+ years experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety
- Significant pharmacovigilance experience (10+ years) relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
- Experience with Signal Detection and safety surveillance
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
- Experience working in large matrix organizations
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancerisk managementsafety evaluationsignal detectionsafety surveillancedata interpretationclinical developmentpost-marketing activitiesdrug development processesdrug approval processes
Soft Skills
communicationefficiencyeffectivenessleadershiporganizational skills
Certifications
PharmDPhDBachelor of Science in Life SciencesBachelor of Science in Medical Sciences