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Director, Pharmacovigilance and Drug Safety
5 days ago
Xenon Boston, United StatesWho We Are: · Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are lookin ...
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Vice President Drug Safety
3 weeks ago
Green Key Resources Boston, United StatesVice President, Drug Safety & Pharmacovigilance · Company: Confidential Biopharmaceutical Company · Location: Boston, MA (Hybrid, relocation required if outside 100 miles of Boston) · Salary Range: $375,000 - $425,000 · Reports to: Senior Vice President, Clinical Development · Co ...
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Director, Pharmacovigilance and Drug Safety
5 days ago
Xenon Pharmaceuticals Inc. Boston, United StatesWho We Are: · Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are lookin ...
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Director, Pharmacovigilance and Drug Safety
5 days ago
Xenon Pharmaceuticals Inc. Boston, United StatesDirector, Pharmacovigilance and Drug Safety (Operations & Compliance) · Boston, MA, USA · Req #265 · Monday, May 6, 2024 · Who We Are: · Who We Are: · Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, ...
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Director, Pharmacovigilance and Drug Safety
4 days ago
Xenon Pharmaceuticals Inc. Boston, United StatesDirector, Pharmacovigilance and Drug Safety (Operations & Compliance) · Boston, MA, USA · Req #265 · Monday, May 6, 2024 · Who We Are: · Who We Are: · Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developi ...
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Director, Pharmacovigilance and Drug Safety
1 week ago
BioTalent Canada Boston, United StatesHome · > · Job Postings · > · Director, Pharmacovigilance and Drug Safety (Operations & Compliance) · Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to i ...
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Director, Pharmacovigilance and Drug Safety
1 week ago
BioTalent Canada Boston, United StatesHome · > · Job Postings · > · Director, Pharmacovigilance and Drug Safety (Operations & Compliance) · Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to ...
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The Elle Group Boston, United StatesThe Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management. · MD degree and board certification preferred · Fi ...
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Senior Medical Director, Drug Safety
4 weeks ago
Klein Hersh Boston, United StatesReporting to the Head of Global PV & Risk Management, the Senior Medical Director will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician ...
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Xenon Boston, United StatesWho We Are: · Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are lookin ...
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Xenon Boston, United StatesWho We Are: · Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are lookin ...
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Xenon Pharmaceuticals Inc. Boston, United StatesWho We Are: · Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are lookin ...
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Senior Medical Director, Global Drug Safety
1 week ago
Alexion Pharmaceuticals, Inc. Boston, United StatesThis is what you will do: · The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines th ...
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Xenon Pharmaceuticals Inc. Boston, United StatesSenior Medical Director, Pharmacovigilance and Drug Safety · Boston, MA, USA · Req #268 · Monday, May 13, 2024 · Who We Are: · Who We Are: · Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and comme ...
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Senior Medical Director, Global Drug Safety
1 week ago
Alexion Pharmaceuticals, Inc. Boston, United StatesThis is what you will do: · The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines th ...
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Xenon Pharmaceuticals Inc. Boston, United StatesDirector/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist) · Boston, MA, USA · Req #236 · Friday, March 8, 2024 · Who We Are: · Who We Are: · Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discoverin ...
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Xenon Pharmaceuticals Inc. Boston, United StatesDirector/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist) · Boston, MA, USA · Req #236 · Friday, March 8, 2024 · Who We Are: · Who We Are: · Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, ...
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Ryder Boston, Massachusetts, , United StatesTruck Driver Class A Home Daily. H - Hazardous Materials Endorsement. · Position Description · Immediate opening for a SOLO Class A CDL Truck Driver and we want the right Trucker to join us in Devens, MA · Call Brisa or Text "Devens" to · https://RyderCareers.Video/CDL-Hiring · ...
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Partners Healthcare System Boston, United States Full timeGENERAL SUMMARY/OVERVIEW STATEMENT · Support quality, safety and risk management in case reviews related to medication safety. · Provide feedback for medication safety related meetings as appropriate. · a. Attends Safety/Risk Team Meetings and Case reviews to review safety relate ...
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Associate Director, Safety Scientist
2 weeks ago
Kura Oncology, Inc. Boston, United StatesAre you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. · At ...
Executive Medical Director, Drug Safety - Boston, United States - Klein Hersh
Description
Our client is a commercial-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade.
We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.
Job ResponsibilitiesManage team of medical professionals and PV Scientists
Provide medical expertise/guidance in the assessment of ICSRs and aggregate drug safety reports
Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports
Contribute to and Oversight of signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and Reference Safety Information (RSI)
Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
Contribute to safety and pharmacovigilance training programs. Provide safety training at investigator meetings
Collaborate with Medical Monitors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials
Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services
Provides strategic planning, implementation, and management of drug safety activities to support clinical development pipeline.
Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
Manages internal staff and external contractors to ensure delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function.
The role will require some travel (approximately 10-15%), and hiring and managing peopleJob Requirements
Medical Degree (MD) from recognized medical school with medical practice experience
8+ years' experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
Experience in managing Medical Professionals and PV Scientists
Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities
Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)
Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
Ability to build relationships, collaborate and influence across disciplines within the company and with outside stakeholders
Experience with MedDRA coding, Points to Consider, AoSE, and SMQs
Excellent verbal, written and presentation skill
Natural ability to communicate and influence effectively to varied audiences
Ability to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations while leading others through the ambiguity and change
Demonstrated ability to solve problems with innovative solutions along with strong organizational skills
Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills
Effective team player, who fosters collaboration within and across functional areas
Sound strategic evaluation, analysis, and decision-making skills
Ability to work in a dynamic, fast paced environment
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