Associate Director/ Director, Drug Safety Surveillance (PV Scientist)
Scorpion Therapeutics, Boston, Massachusetts, us, 02298
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Role Summary The Associate Director/Director of Drug Safety Surveillance (PV Scientist) provides safety science and pharmacovigilance support to assigned molecules within the Ionis portfolio. Major areas of responsibility include ensuring high quality of aggregate report production, development of risk‑management documents in collaboration with Drug Safety Physicians, safety review meeting coordination, signal detection activities, and evaluating emerging safety data from all sources. The role includes identifying and managing safety signals, authoring key sections of periodic safety reports and other PV documents, and providing safety support for clinical development. This position reports to the Executive Director of Drug Safety Surveillance within Drug Safety/PV.
Responsibilities
Reports, PSURs/PBRERs, ad‑hoc safety requests from Health Authorities, and other global periodic safety reports
Support the development and review of appropriate safety sections of key product documents, including: IBs (including RSI determination), study protocols, ICF, CSRs, CCDS, RMP, REMS
Review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports
Support safety signal detection and assessment activities, including identification and validation of possible trends and concerns related to Ionis products and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety
Perform literature surveillance, identify safety issues from published medical literature, summarize relevant publications for inclusion in safety periodic reports
Support projects or other initiatives from cross‑functional groups and departments (Clinical Development, Regulatory Affairs, Data Management, Quality, Toxicology, etc.)
Bring safety expertise to interactions with internal stakeholders, Health Authorities and Data Monitoring Committees
Monitor industry best practices, changes in global safety regulations and guidelines for marketed and investigational products and recommend changes and upgrades to existing departmental policies, SOPs, and systems as appropriate
May also participate in other activities as required to support the day‑to‑day functioning of the Drug Safety group
Skills
Solid understanding and working knowledge of US and ex‑US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
Experience in pre‑ and post‑approval pharmacovigilance activities, including safety reporting, signal detection activities (safety data analysis, categorization, assessment)
Ability to interact effectively in a multifunctional and multicultural team setting
Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize scientific data
Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines
Ability to work independently, manage work priorities, build collaborative team relationships at all levels and remain flexible to the needs of the teams/projects
Qualifications
Required: Bachelor’s degree in life sciences and 12 years of related experience in pharmacovigilance in a pharmaceutical or biotechnology company
Preferred: Advanced degree in a healthcare profession strongly preferred (e.g., MD, PharmD, PhD with at least 5 years of related experience)
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Role Summary The Associate Director/Director of Drug Safety Surveillance (PV Scientist) provides safety science and pharmacovigilance support to assigned molecules within the Ionis portfolio. Major areas of responsibility include ensuring high quality of aggregate report production, development of risk‑management documents in collaboration with Drug Safety Physicians, safety review meeting coordination, signal detection activities, and evaluating emerging safety data from all sources. The role includes identifying and managing safety signals, authoring key sections of periodic safety reports and other PV documents, and providing safety support for clinical development. This position reports to the Executive Director of Drug Safety Surveillance within Drug Safety/PV.
Responsibilities
Reports, PSURs/PBRERs, ad‑hoc safety requests from Health Authorities, and other global periodic safety reports
Support the development and review of appropriate safety sections of key product documents, including: IBs (including RSI determination), study protocols, ICF, CSRs, CCDS, RMP, REMS
Review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports
Support safety signal detection and assessment activities, including identification and validation of possible trends and concerns related to Ionis products and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety
Perform literature surveillance, identify safety issues from published medical literature, summarize relevant publications for inclusion in safety periodic reports
Support projects or other initiatives from cross‑functional groups and departments (Clinical Development, Regulatory Affairs, Data Management, Quality, Toxicology, etc.)
Bring safety expertise to interactions with internal stakeholders, Health Authorities and Data Monitoring Committees
Monitor industry best practices, changes in global safety regulations and guidelines for marketed and investigational products and recommend changes and upgrades to existing departmental policies, SOPs, and systems as appropriate
May also participate in other activities as required to support the day‑to‑day functioning of the Drug Safety group
Skills
Solid understanding and working knowledge of US and ex‑US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
Experience in pre‑ and post‑approval pharmacovigilance activities, including safety reporting, signal detection activities (safety data analysis, categorization, assessment)
Ability to interact effectively in a multifunctional and multicultural team setting
Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize scientific data
Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines
Ability to work independently, manage work priorities, build collaborative team relationships at all levels and remain flexible to the needs of the teams/projects
Qualifications
Required: Bachelor’s degree in life sciences and 12 years of related experience in pharmacovigilance in a pharmaceutical or biotechnology company
Preferred: Advanced degree in a healthcare profession strongly preferred (e.g., MD, PharmD, PhD with at least 5 years of related experience)
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