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Pharmacovigilance Manager
Thermo Fisher Scientific. Manage and optimize drug safety operations for clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing drug safety operations and regulatory compliance for clinical trials, with strong leadership capabilities in staff management and project planning. Proficient in pharmacovigilance and maintaining communication across functional groups to enhance operational efficiency.
Highest-signal resume keywords
Drug Safety Operations ManagementGlobal Regulatory ComplianceLeadership ExperienceProject Management SkillsPharmacovigilance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety ExperienceProject PlanningRegulatory Requirements KnowledgeTherapeutic Areas KnowledgePathophysiology UnderstandingMicrosoft Office ProficiencySafety Databases Proficiency
Soft Skills
Communication SkillsAttention to DetailCritical ThinkingProblem-Solving SkillsDecision-Making Skills
Certifications & Qualifications
Bachelor's Degree or Equivalent
Industry Keywords
PharmacovigilanceClinical TrialsAdverse Events ProcessingProcedural ComplianceCase-Intake Coverage
About the role
Key responsibilities & impact- Manage and optimize drug safety operations for clinical trials
- Manage contractual, procedural, and regulatory requirements across local and global projects
- Maintain communication with functional groups regarding program and company issues
- Collaborate on problem solving and systems improvement
- Review pharmacovigilance publications and information sources to stay current on regulations, practices, procedures, and proposals
- Maintain basic medical understanding of applicable therapeutic areas and disease states
- Participate in on-call duties and ensure 24-hour case-intake coverage when required
- Provide project plans and accurate forecasts
- Serve as a resource for departmental managers and lead departmental initiatives
- Prepare and present proposals
- Manage experienced professional staff, including hiring, development, performance management, coaching, counseling, and separations
- Approve salary administration, hiring, corrective action, terminations, time records, expense reports, leave requests, and overtime
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic/vocational qualification, including 3+ years of safety experience
- Previous experience comparable to 5+ years
- 1+ year of leadership responsibility
- Working knowledge of global regulatory requirements and procedural compliance
- Strong knowledge of relevant therapeutic areas for processing adverse events
- General knowledge of pathophysiology and disease processes
- Time management and project management skills
- Proficiency in Microsoft Office products and safety databases
- Good command of English and ability to translate information into local language where required
- Excellent oral and written communication skills
- Strong attention to detail and accuracy
- Strong critical thinking, problem-solving, and decision-making skills
Benefits
Comp & perks- Collaboration and development opportunities
- Global team environment
- Scientific excellence-focused work environment