Associate Director/ Director, Drug Safety Surveillance (PV Scientist)
About the position
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! ASSOCIATE DIRECTOR/ DIRECTOR, DRUG SAFETY SURVEILLANCE (PV SCIENTIST) SUMMARY: The Associate Director/Director of Drug Safety Surveillance (PV Scientist) provides safety science and pharmacovigilance support to assigned molecules within Ionis portfolio. Major areas of responsibilities 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 as well as evaluating emerging safety data from all sources, identifying and managing safety signal(s), authoring key sections of periodic safety reports and other PV documents, and providing safety support for clinical development. This position will report 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 issue 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 recommends 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
Requirements
• Bachelor’s degree in life sciences and 12 years of related experience in pharmacovigilance in a pharmaceutical or biotechnology company
• 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)
• Experienced 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
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Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! ASSOCIATE DIRECTOR/ DIRECTOR, DRUG SAFETY SURVEILLANCE (PV SCIENTIST) SUMMARY: The Associate Director/Director of Drug Safety Surveillance (PV Scientist) provides safety science and pharmacovigilance support to assigned molecules within Ionis portfolio. Major areas of responsibilities 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 as well as evaluating emerging safety data from all sources, identifying and managing safety signal(s), authoring key sections of periodic safety reports and other PV documents, and providing safety support for clinical development. This position will report 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 issue 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 recommends 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
Requirements
• Bachelor’s degree in life sciences and 12 years of related experience in pharmacovigilance in a pharmaceutical or biotechnology company
• 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)
• Experienced 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
Apply tot his job
Apply To this Job