Associate Director, Pharmacovigilance Scientist
Tango Therapeutics
August 21, 2026
Remote friendly (Boston, MA)
United States
Medical Affairs
Responsibilities:
- Lead and oversee ongoing safety surveillance (signal detection activities and literature reviews) for assigned programs, ensuring compliance with global regulatory requirements and company objectives.
- Serve as safety subject matter expert for assigned programs; drive benefit-risk assessment, signal detection, risk management, and safety governance with drug safety leadership and cross-functional teams.
- Author and contribute to safety deliverables including DSURs, PSURs/PBRERs, Safety Assessment Reports, Reference Safety Information (RSI), and ADR in DCSI/CCSI.
- Review and contribute to clinical trial documents including protocols, informed consent forms, and Investigator’s Brochure.
- Analyze and present safety data to define product risk profile and inform risk management.
- Partner with Pharmacovigilance Operations to enhance and maintain a scalable global drug safety/pharmacovigilance framework for clinical and post-marketing.
- Develop/optimize tools and processes for pharmacovigilance, signal detection, and benefit-risk management.
- Support safety committee and data monitoring committee activities.
- Collaborate with partners on drug safety-related activities for co-development/co-marketing.
- Ensure compliance with regulatory guidelines and internal processes for audits/inspections; participate in audit/inspection activities.
- Maintain up-to-date knowledge of FDA/ICH guidelines, EU PV regulations, and other global PV legislation.
Qualifications:
- 8+ years drug safety and pharmacovigilance experience in biotech/pharma, including 3+ years in pharmacovigilance sciences.
- Bachelor’s degree required (scientific/healthcare); MS, PharmD, PhD, MD, or RN strongly preferred.
- Strong drug safety and regulatory knowledge (ideally oncology).
- Signal detection and lifecycle safety information management skills.
- Experience authoring aggregate safety reports (DSURs, PSURs/PBRERs) and safety sections of clinical trial documents (IB, RSI).
- Expertise in global PV regulations, GVP, and ICH guidelines; safety systems and drug development processes.
- Ability to translate complex safety data into actionable regulatory/clinical recommendations.
- US and EU marketing license submission experience preferred.
- Self-motivated, flexible, able to prioritize/multitask in a fast-paced environment; strong organizational/project management.
- Excellent communication and cross-functional collaboration.
Benefits/Compensation/Application instructions:
- Salary range: $161,600—$242,400 USD.
- Lead and oversee ongoing safety surveillance (signal detection activities and literature reviews) for assigned programs, ensuring compliance with global regulatory requirements and company objectives.
- Serve as safety subject matter expert for assigned programs; drive benefit-risk assessment, signal detection, risk management, and safety governance with drug safety leadership and cross-functional teams.
- Author and contribute to safety deliverables including DSURs, PSURs/PBRERs, Safety Assessment Reports, Reference Safety Information (RSI), and ADR in DCSI/CCSI.
- Review and contribute to clinical trial documents including protocols, informed consent forms, and Investigator’s Brochure.
- Analyze and present safety data to define product risk profile and inform risk management.
- Partner with Pharmacovigilance Operations to enhance and maintain a scalable global drug safety/pharmacovigilance framework for clinical and post-marketing.
- Develop/optimize tools and processes for pharmacovigilance, signal detection, and benefit-risk management.
- Support safety committee and data monitoring committee activities.
- Collaborate with partners on drug safety-related activities for co-development/co-marketing.
- Ensure compliance with regulatory guidelines and internal processes for audits/inspections; participate in audit/inspection activities.
- Maintain up-to-date knowledge of FDA/ICH guidelines, EU PV regulations, and other global PV legislation.
Qualifications:
- 8+ years drug safety and pharmacovigilance experience in biotech/pharma, including 3+ years in pharmacovigilance sciences.
- Bachelor’s degree required (scientific/healthcare); MS, PharmD, PhD, MD, or RN strongly preferred.
- Strong drug safety and regulatory knowledge (ideally oncology).
- Signal detection and lifecycle safety information management skills.
- Experience authoring aggregate safety reports (DSURs, PSURs/PBRERs) and safety sections of clinical trial documents (IB, RSI).
- Expertise in global PV regulations, GVP, and ICH guidelines; safety systems and drug development processes.
- Ability to translate complex safety data into actionable regulatory/clinical recommendations.
- US and EU marketing license submission experience preferred.
- Self-motivated, flexible, able to prioritize/multitask in a fast-paced environment; strong organizational/project management.
- Excellent communication and cross-functional collaboration.
Benefits/Compensation/Application instructions:
- Salary range: $161,600—$242,400 USD.