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Associate Medical Director, Drug Safety
BiogenDrug Safety Physician responsible for global pharmacovigilance at Biogen. Analyzing safety data, designing clinical trials, and managing product benefit-risk profiles.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in global pharmacovigilance, safety data analysis, and clinical trial design, with a strong focus on benefit-risk management and regulatory compliance in both US and EU markets.
Highest-signal resume keywords
MDPharmacovigilance ExperienceClinical Trial DesignSafety Data AnalysisKnowledge of US and EU Regulations
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Safety Signal InvestigationBenefit-Risk Profile ManagementPeriodic Safety ReportingExpedited Safety ReportingClinical Development Strategy
Soft Skills
LeadershipCommunicationCollaboration
Industry Keywords
Pharmaceutical IndustryNeurosciencePsychiatryImmunologyRare Diseases
About the role
Key responsibilities & impact- Responsible for global pharmacovigilance for investigational and/or marketed products
- Review and analyze safety data
- Design clinical trials
- Identify and investigate safety signals
- Manage benefit-risk profile for assigned compounds and products
- Represent Biogen Safety in internal and external meetings
- Provide safety strategic leadership for clinical development programs
- Ensure the accurate completion and reporting of periodic and expedited safety reports
Requirements
What you’ll need- MD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred.
- Minimum 3+ years’ experience in the pharmaceutical industry or clinical care setting; ideally 1+ years of overall experience specific to pharmacovigilance.
- Prior experience in clinical trials; academic and/or industry.
- Knowledge of pre- and post- marketing US and EU regulations
Benefits
Comp & perks- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation