SummaryThe Associate Director, Pharmacovigilance Scientist, reporting to the Senior Director, Drug Safety, plays a pivotal role, partnering closely across the organization to evaluate drug safety data, manage adverse event signals and author regulatory safety reports across the product lifecycle from first-in-human studies through global registration and commercialization.
This role is responsible for high-quality safety surveillance activities including aggregate report production, safety governance meeting coordination, safety signal detection and assessment and safety risk management activities for assigned Tango products.
This role is accountable for proactively and continuously evaluating and clearly communicating benefit-risk profiles across the product lifecycle-ensuring alignment with global regulatory expectations, pharmacovigilance standards, and industry best practices, while enabling confident, data-driven development and commercialization decisions.
Your Role- Lead and oversee ongoing safety surveillance (including signal detection activities and literature reviews) for assigned programs, ensuring compliance with global regulatory requirements and company objectives
- Contribute as the safety subject matter expert for assigned programs, driving benefit-risk assessment, signal detection, risk management, and safety governance in partnership with drug safety leadership and cross-functional teams
- Author and contribute to key safety deliverables, including DSURs, PSURs/PBRERs, Safety Assessment Reports for potential signals/risks, Reference Safety Information (RSI) and ADR in the DCSI/CCSI
- Provide safety review and contribute to various clinical trial documents including but not limited to protocols, informed consent forms, Investigator's Brochure
- Provide analyses and presentation of safety data and messages to define the product risk profile and inform risk management
- Partner with the Pharmacovigilance Operations team to enhance, and maintain a scalable global drug safety and pharmacovigilance framework supporting both clinical development and post-marketing activities
- Contribute to the development and optimization of new tools and processes by applying industry best practices, emerging methodologies, and evolving trends in pharmacovigilance, signal detection, and benefit-risk management
- Contribute to the planning and conduct of safety committee and data monitoring committee activities
- Collaborate with Partner for co-development or co-marketing, when applicable, with regards to drug safety related activities
- Ensure compliance with regulatory guidelines and internal processes and procedures in preparation of audits and inspections
- Participate in audit and inspection activities, as required
- Maintain up-to-date knowledge of relevant current FDA, ICH guidelines, EU PV regulations and other PV legislation globally
What You Bring- 8+ years of drug safety and pharmacovigilance experience within the biotechnology and/or pharmaceutical industry with at least 3 years in pharmacovigilance sciences
- Bachelor's degree in a scientific or health care related discipline required, advanced degree (MS, PharmD, PhD, MD, RN) strongly preferred
- Strong drug safety and regulatory knowledge, ideally in oncology
- Skilled in signal detection processes and managing safety information across the product life cycle
- Experience authoring aggregates safety reports including DSURs, PSURs/PBRERs and safety-related sections of clinical trial documents such as IB and RSI
- Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems and drug development processes
- Ability to translate complex safety data into actionable recommendations and identify alternative solutions for regulatory and clinical decision-making.
- Experience in regulatory submissions for marketing license applications in the US and in EU preferred
- Self-motivated, flexible, able to prioritize, multitask and work in a fast-paced and demanding environment.
- Strong organizational and project management skills
- Excellent communication and cross-functional collaboration skills
