Associate Director, Safety Scientist
BioNTech SE
4 months ago
Remote friendly (Cambridge, MA)
United States
$146,300 - $234,100 USD yearly
Operations
Associate Director, Safety Sciences
Your Contribution (Responsibilities):
- Perform cumulative safety data reviews across trials or programs to assess safety profiles and identify emerging risks or trends
- Oversee Safety Surveillance activities, including signal detection, literature reviews, and aggregate safety data analysis using tools like Safety Dashboards, Spotfire, and Elluminate
- Collaborate with Safety Physicians to review and align on safety data conclusions for informed decision-making for assigned program(s)
- Author periodic reports such as DSURs, PSURs, PBRERs, Risk Management Plans (RMPs), and provide input into structured Benefit Risk Assessments (sBRAs)
- Provide input into regulatory submissions (e.g., BLA, Module 2.7.4/2.5) and respond to Health Authority queries with scientifically sound responses
- Contribute or serve as primary safety contact for clinical trial-related documents (IBs, CSRs, ICFs, SAPs, and eCRF setup)
- Mentor new team members with training on core safety processes
- Act as Subject Matter Expert during audits and inspections for key safety processes
A Good Match (Qualifications/Skills):
- Advanced degree in life sciences/healthcare; PhD or post-doctoral pharmacovigilance certification preferred
- 5+ years clinical research experience with significant pharmacovigilance exposure in biotech/pharma or CROs
- Expert knowledge of pharmacovigilance laws/regulations and GCP/GVP guidelines
- Proven experience designing/implementing clinical safety processes/tools and assessing/reporting safety data
- Strong communication skills; proactive, solution-oriented mindset; high ethical standards
- Fluency in written and spoken English
Expected Pay Range:
- $146,300/year to $234,100/year + benefits, annual bonus & equity (variable)
Your Benefits (selected):
- Medical, Dental and Vision Insurance; Life/AD&D/Critical Illness Insurance; pre-tax HSA/FSA and spending accounts
- 401(K) plan with company match; Tuition reimbursement/student loan assistance; Paid Time Off; EAP (24/7)
Application Instructions:
- Apply for the listed locations by submitting your documents via the online form.
Your Contribution (Responsibilities):
- Perform cumulative safety data reviews across trials or programs to assess safety profiles and identify emerging risks or trends
- Oversee Safety Surveillance activities, including signal detection, literature reviews, and aggregate safety data analysis using tools like Safety Dashboards, Spotfire, and Elluminate
- Collaborate with Safety Physicians to review and align on safety data conclusions for informed decision-making for assigned program(s)
- Author periodic reports such as DSURs, PSURs, PBRERs, Risk Management Plans (RMPs), and provide input into structured Benefit Risk Assessments (sBRAs)
- Provide input into regulatory submissions (e.g., BLA, Module 2.7.4/2.5) and respond to Health Authority queries with scientifically sound responses
- Contribute or serve as primary safety contact for clinical trial-related documents (IBs, CSRs, ICFs, SAPs, and eCRF setup)
- Mentor new team members with training on core safety processes
- Act as Subject Matter Expert during audits and inspections for key safety processes
A Good Match (Qualifications/Skills):
- Advanced degree in life sciences/healthcare; PhD or post-doctoral pharmacovigilance certification preferred
- 5+ years clinical research experience with significant pharmacovigilance exposure in biotech/pharma or CROs
- Expert knowledge of pharmacovigilance laws/regulations and GCP/GVP guidelines
- Proven experience designing/implementing clinical safety processes/tools and assessing/reporting safety data
- Strong communication skills; proactive, solution-oriented mindset; high ethical standards
- Fluency in written and spoken English
Expected Pay Range:
- $146,300/year to $234,100/year + benefits, annual bonus & equity (variable)
Your Benefits (selected):
- Medical, Dental and Vision Insurance; Life/AD&D/Critical Illness Insurance; pre-tax HSA/FSA and spending accounts
- 401(K) plan with company match; Tuition reimbursement/student loan assistance; Paid Time Off; EAP (24/7)
Application Instructions:
- Apply for the listed locations by submitting your documents via the online form.