Senior Director, Drug Safety and Pharmacovigilance

Found in: Jooble US O C2 - 2 weeks ago

Waltham MA, United States Dyne Tx Full time

Senior Director, Drug Safety and Pharmacovigilance
With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in delivery to muscle tissue.Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonicdystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit , and follow us on X ,LinkedIn andFacebook . 
The Senior Director, Drug Safety and Pharmacovigilance will play a key leadership role in characterizing the safety profiles of Dyne products and mitigating and communicating their risks throughout the product lifecycle (from First-In-Human to post-marketing). This role will provide short- and long-term strategic leadership of safety surveillance for Dyne’s clinical development programs, including resource planning and long-range capability development to ensure high quality characterization of the safety profiles of Dyne molecules and compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management. This role will oversee cross-functional Signal Detection and Safety Surveillance Teams, guiding the analysis, interpretation and presentation of safety data to stakeholders as needed. This role also contributes to the safety content of regulatory and study documents and collaborates actively with colleagues in numerous cross-functional departments.
This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.
Conduct and/or oversee activities related to signal detection and evaluation, risk classification, management and communication, including leadership of Signal Detection and Safety Surveillance Teams, as part of continuous benefit-risk evaluation throughout the lifecycle of Dyne products from First-in-Human (FIH) to post-marketing
Review safety data of non-clinical studies and from other sources to inform clinical development safety monitoring strategies and plans, including identification of safety-related biomarkers
Contribute to the Safety Governance process through the preparation and presentation of safety data and provision of recommendations for review and approval by the Safety Management Committee
Perform medical review of ICSRs in Dyne’s Global Safety Database including but not limited to case narrative, MedDRA coding, causality, company comment and queries
Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), IB Reference Safety Information (RSI), Clinical Study Reports (CSR), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, and other relevant documents
Assist the Head of Pharmacovigilance and PV Operations to prepare and maintain safety related SOPs in compliance with the global safety regulations and guidelines and provide relevant training as needed
Assist in planning the Pharmacovigilance Department budget, develop short-term and long-term goals for the department in accordance with overall Company and Development strategies
Review safety content of scientific publications such as posters, abstracts, and manuscripts.
Participate in cross-functional projects and teams
completion of an accredited medical or surgical residency program and board certification are preferred
Minimum 12 years’ experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including cross-functional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development
Experience with safety data visualization tools and other technologies supporting safety surveillance
Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other local/global safety regulations, and ability to integrate relevant aspects of these documents into safety surveillance and reporting
Line management / direct reports experience is strongly preferred
Proven abilities to lead significant process improvements in PS
Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively inform the conduct of safety surveillance
Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
#

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: Jooble US O C2 - 2 weeks ago

    Waltham, MA, United States Dyne Tx Full time

    Our commitment to people with muscle diseases is our greatest strength Senior Director, Drug Safety and Pharmacovigilance Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing...

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: Jooble US O C2 - 1 week ago

    Boston, MA, United States The Elle Group Full time

    The 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 - First in Human-Post Marketing experience - 7+ years of experience as a safety...

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: beBee S US - 2 weeks ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Drug Safety/Pharmacovigilance

    Found in: Appcast Linkedin GBL C2 - 1 week ago

    Waltham, United States Talent Groups Full time

    Experience processing Oncology casesHave demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance related to pharmacovigilance and Good Clinical PracticesAbility to make clinical decisions and formulate appropriate queries based on sound medical knowledgeCompetence with commercial safety...

  • Drug Safety/Pharmacovigilance

    Found in: Appcast US C2 - 1 week ago

    Waltham, United States Talent Groups Full time

    Experience processing Oncology casesHave demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance related to pharmacovigilance and Good Clinical PracticesAbility to make clinical decisions and formulate appropriate queries based on sound medical knowledgeCompetence with commercial safety...

  • VP, Drug Safety

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Meet Full time

    An exciting opportunity with a pioneering pharmaceutical company dedicated to advancing healthcare through innovative drug development within Neurology. With a focus on breakthrough therapies, striving to improve the lives of patients worldwide. Position Overview: This innovative organization is looking to bring on a highly experienced and dynamic VP,...

  • Medical Director, Pharmacovigilance

    Found in: Resume Library US A2 - 1 week ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description We are seeking a Medical Director.  This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office. The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing...

  • Director, Pharmacovigilance Operations

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Tango Therapeutics Full time

    Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...

  • Drug Safety Associate

    6 days ago

    Waltham, United States Talent Groups Full time

    3-5 years drug safety or clinical safety experience – RequiredA clinical degree (e.g., RPh/PharmD, BSN, RN) – RequiredTwo years clinical experience in a medical setting, demonstrate general medical and pharmacology knowledge – RequiredPrior experience in drug safety within the pharmaceutical or biotechnology industry.In-depth knowledge of global...

  • Drug Safety Associate

    Found in: Appcast Linkedin GBL C2 - 7 days ago

    Waltham, United States Talent Groups Full time

    3-5 years drug safety or clinical safety experience – RequiredA clinical degree (e.g., RPh/PharmD, BSN, RN) – RequiredTwo years clinical experience in a medical setting, demonstrate general medical and pharmacology knowledge – RequiredPrior experience in drug safety within the pharmaceutical or biotechnology industry.In-depth knowledge of global...

  • Drug Safety Associate

    Found in: Appcast US C2 - 6 days ago

    Waltham, United States Talent Groups Full time

    3-5 years drug safety or clinical safety experience – RequiredA clinical degree (e.g., RPh/PharmD, BSN, RN) – RequiredTwo years clinical experience in a medical setting, demonstrate general medical and pharmacology knowledge – RequiredPrior experience in drug safety within the pharmaceutical or biotechnology industry.In-depth knowledge of global...

  • Senior Manager, Pharmacovigilance and Risk Management

    Found in: Resume Library US A2 - 1 week ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description The Associate Director/Senior Manager, Pharmacovigilance and Risk Management, serves as a critical medical and data analytical role for the assigned investigational and/or marketed product(s). The successful candidate is expected to be equally effective working independently as well as collaboratively. She/he must possess knowledge and...

  • Head of Pharmacovigilance Operations and Compliance

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Tango Therapeutics Full time

    Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...

  • Drug Safety Specialist

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Waltham, United States GForce Life Sciences Full time

    Duration: 6-month contractLocation: Onsite in Waltham - 3 days onsite, 2 days wfhStart 2 weeks from an offerResponsibilities: Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH...

  • Drug Safety Specialist

    Found in: Appcast US C2 - 1 week ago

    Waltham, United States GForce Life Sciences Full time

    Duration: 6-month contractLocation: Onsite in Waltham - 3 days onsite, 2 days wfhStart 2 weeks from an offerResponsibilities: Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH...

  • Senior Manager, Pharmacovigilance and Risk Management

    2 days ago

    Waltham, United States Deciphera Pharmaceuticals Full time

    Job DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...

  • Pharmacovigilance Manager

    Found in: Appcast US C2 - 1 week ago

    Waltham, United States GQR Full time

    Join us at the forefront of rare disease research. Our client is a clinical-stage company developing gene therapies for multiple rare childhood diseases. They place enormous value on people, and consider the progress and well-being of their team members to be as important as the progress of their pipeline. For this role, they are looking for hands-on...

  • Pharmacovigilance Manager

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Waltham, United States GQR Full time

    Join us at the forefront of rare disease research. Our client is a clinical-stage company developing gene therapies for multiple rare childhood diseases. They place enormous value on people, and consider the progress and well-being of their team members to be as important as the progress of their pipeline. For this role, they are looking for hands-on...

  • Senior Manager, Pharmacovigilance Quality

    Found in: Resume Library US A2 - 1 week ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description The Senior Manager, Pharmacovigilance (PV) Quality encompasses a key leadership role in providing direction to the PV department and promote the spirit of proactive, continuous quality improvement in adverse event case management for all Deciphera Pharmaceuticals Clinical Trials, Extended Access Programs and post marketing (where...