Current jobs related to Director/Senior Director, Pharmacovigilance and Drug Safety - Boston - Xenon
-
Director, Pharmacovigilance and Drug Safety
2 weeks ago
Boston, United States Accoravillage Full timeDirector, Pharmacovigilance and Drug Safety (Safety Science)Boston, MA, USA Req #259Friday, July 12, 2024Who 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...
-
Boston, United States AVEO Oncology Full timeJob DescriptionJob DescriptionJOB TITLE: Director of Pharmacovigilance Quality and Alliance ManagementLOCATION: Boston or RemoteJOB SUMMARY: The Director of Pharmacovigilance Quality and Alliance Management will be a pivotal member of the Pharmacovigilance (PV)team, responsible for ensuring the highest standards of drug safety and compliance within Aveo...
-
Senior Medical Director, Global Drug Safety
2 months ago
Boston, United States Alexion Full timeThis 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 the Safety Surveillance and Risk Management strategy and ensures its execution...
-
Boston, United States Takeda Pharmaceuticals Full timeJob DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...
-
Boston, United States Takeda Pharmaceuticals Full timeJob Description About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...
-
Vice President, Head of Safety
2 months ago
Boston, United States Astria Therapeutics, Inc. Full timePosition Overview:Astria is seeking an innovative and collaborative individual who will play a pivotal role in fostering a culture of safety within the company ensuring that Astria remains at the forefront of patient safety and pharmacovigilance. The individual will be responsible for the strategic implementation, execution, and management of...
-
Vice President, Head of Safety
2 months ago
Boston, United States Astria Therapeutics, Inc. Full timePosition Overview:Astria is seeking an innovative and collaborative individual who will play a pivotal role in fostering a culture of safety within the company ensuring that Astria remains at the forefront of patient safety and pharmacovigilance. The individual will be responsible for the strategic implementation, execution, and management of...
-
Head of Pharmacovigilance
3 months ago
Boston, United States AVEO Oncology Full timeJob DescriptionJob DescriptionJOB TITLE: Head of Pharmacovigilance (MD)DEPARTMENT: Clinical DevelopmentDATE PREPARED: May 30, 2024 JOB SUMMARY: The Head of Pharmacovigilance will oversee Global Safety across all AVEO marketed products and pipeline assets. This person will play an integral role in building a Pharmacovigilance infrastructure for a rapidly...
-
Senior Director, Drug Substance
4 months ago
Boston, United States PepGen Full timeJob DescriptionJob DescriptionSenior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team. This person will manage the drug substance needs of PepGen’s growing...
-
Senior Director, Head of Drug Substance
2 weeks ago
boston, United States Astria Therapeutics, Inc. Full timeTitle: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...
-
Senior Director, Head of Drug Substance
2 weeks ago
boston, United States Astria Therapeutics, Inc. Full timeTitle: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...
-
Senior Director, Head of Drug Substance
3 months ago
Boston, United States Astria Therapeutics, Inc. Full timeTitle: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...
-
Senior Director, Head of Drug Substance
3 months ago
Boston, United States Astria Therapeutics, Inc. Full timeTitle: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...
-
Podiatrist - Medical Director Services PC
2 weeks ago
Boston, Massachusetts, United States Medical Director Services PC Full timeJob Summary:Medical Director Services PC is seeking an experienced Podiatrist to provide professional and medical podiatric services to patients with conditions affecting the foot, ankle, and related structures in skilled nursing facilities throughout Massachusetts. Inquire about availability in other states as well.Key Responsibilities:Provide essential...
-
Boston, Massachusetts, United States Katalyst Healthcares & Life Sciences Full time{"title": "Pharmacovigilance Quality Assurance Project Lead", "content": "Job SummaryKatalyst Healthcares & Life Sciences is seeking a highly skilled Pharmacovigilance Quality Assurance Project Lead to develop and oversee the execution of our global PV QA audit strategy, inspection readiness, and vendor oversight. The successful candidate will have a strong...
-
Director of Security and Safety
2 weeks ago
Boston, United States The Tailored Closet and PremierGarage of Nashville Full timeReporting to the Chief Security Officer, the Director of Security and Safetyis a professional responsible for overseeing and implementing security measures to protect an organization's physical assets, people, and information. The role involves developing and managing strategies, policies, and controls to ensure a secure and safe environment.The Director of...
-
Director Drug Substance Development
4 weeks ago
Boston, United States STEMSourcing Full timeOur valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...
-
Director Drug Substance Development
2 weeks ago
boston, United States STEMSourcing Full timeOur valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...
-
Director Drug Substance Development
1 month ago
Boston, United States STEMSourcing Full timeOur valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...
-
Director Drug Substance Development
2 weeks ago
boston, United States STEMSourcing Full timeOur valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...
Director/Senior Director, Pharmacovigilance and Drug Safety
4 months ago
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 looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.
What We Do:
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our XEN1101 Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 clinical trials in patients with focal onset seizures and primary generalized tonic clonic seizures. In 2024, we are planning to initiate a Phase 3 XEN1101 program in major depressive disorder, based on topline data from our XEN1101 Phase 2 "X-NOVA" clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.
About the Role:
We are seeking a Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist) to join our team. The incumbent is responsible for safety surveillance and aggregate safety reports and works with safety physicians for signal/risk management for assigned Xenon's products to support product safety and compliance with global drug safety regulations and departmental procedures and provide vendor oversight to CROs. The individual authors safety documents, reviews safety sections of other documents for Xenon products throughout the product lifecycle from First-in-Human (FIH) to post-marketing, performs QC and maintains document control of safety documents. This individual will organize cross-functional Safety Management Team meetings and collaborate with colleagues in Clinical Development, Trial Operations, Clinical Pharmacology, Biostatistics & Programming, Regulatory, Medical Affairs, non-clinical safety lead, QA and Legal departments. This individual oversees the ICSR data quality from safety vendors and ensures compliance with all applicable US and foreign legal and regulatory requirements for signal detection, evaluation & risk management of products.
This position reports to the Senior Vice President, Pharmacovigilance and Drug Safety and will be in Boston, MA, USA. The level of the position will be commensurate with the candidate's education and industry experience.
RESPONSIBILITIES:
- Build scientific function of safety surveillance and aggregate safety reports, author safety signal assessment reports and aggregate safety reports, write and maintain relevant SOPs and procedures in compliance with global safety regulations and guidelines, and provide training within DSPV and cross-functionally
- Lead and manage all medical safety and risk management related projects including planning, tracking and execution; provide vendor oversight for quality of ICSRs, similar case analysis, and aggregate safety reporting; lead initiatives from the scientific and PV regulation perspective such as inspection readiness, and launch readiness
- Organize and facilitate cross-functional Safety Management Team (SMT) meetings for signal management, risk management detect, and benefit-risk assessment for Xenon products, prepare the meeting minutes, and track actions
- Compile safety information for aggregate safety reports in support of periodic safety data review meetings.
- Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and develop strategies for safety assessment in collaboration with the Head of DSPV and safety physicians
- Review and communicate trending, signaling, and other safety-related issues originating from any source for the purposes of detecting and reviewing safety signals (e.g., change in frequency, nature, or severity of a safety-related issue) in a timely manner
- Review potential issues and safety signals and contribute to the Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic / aggregate safety data reviews, and provide recommendations for review and approval by the Safety Advisory Committee
- Lead across cross-functional teams including but not limited to Non-clinical, Clinical Development, Trial Operations Operations Regulatory, Biostatistics, and Clinical Data Management to generate cross-functional safety documents such as DSUR and RMP
- Author safety-related documents for Xenon products throughout product lifecycle from FIH to post-marketing, including Similar Case Analysis, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g., DSUR, PBRER, PSUR, PADER), RMP/developmental RMP, and responses to ad-hoc requests for safety information internally and externally
- Provide safety data and review IND Annual Reports in collaboration with other stakeholders
- Review SMP, and provide input to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), and other relevant documents
- Perform medical review of Individual Case Safety Reports (ICSR) including fields such as case narrative, MedDRA coding, labeling, causality and company comment, and oversee the data quality of ICSR from safety vendors
- Provide oversight of MedDRA and WHO Drug coding
- Schedule meetings for safety teams, clinical teams and vendors for follow-up queries and company causality assessment for SAEs, pregnancy and special cases in clinical trials.
- Perform QC (quality control) for multiple tasks and data reconciliation of between the Clinical and the Safety Database
- Document Control: maintain electronic files for relevant DSPV documents on the Xenon SharePoint or shared drives or other system
- Assist department head to facilitate department meetings; prepare agendas and meeting minutes; assist with vendor management and oversight
- Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
- Other duties as assigned
QUALIFICATIONS:
- Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 10-12+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments
- Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
- Skilled in signal detection process and managing safety information from clinical development and post-marketing sources
- Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management
- Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
- Experience with use of safety databases, preferably Argus Safety Database
- Excellent verbal and written communication skills with ability to write clearly and concisely, and strong presentation skills
- Time management skills with ability to prioritize to meet required deadlines
- Ability to multitask and prioritize under tight deadlines while providing attention to detail and high-quality work in a dynamic environment
- Ability to be flexible, adapt to change, work independently, as well as experience working in a highly collaborative matrix environment
The base salary range for this role is $210,000 to $296,200 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.
Apply Now
