Director, Pharmacovigilance Scientist
4 weeks ago
The Position
Verve is seeking a director level pharmacovigilance (PV) Scientist. This is an individual contributor role and an exciting opportunity to be on the ground floor of a developing PV department working on cutting-edge therapies. This role will provide day-to-day oversight of safety monitoring activities and safety operations as well as management of outsourced PV activities. This individual will be partnering with cross-functional teams by providing PV guidance for clinical trials across Verve's growing gene editing pipeline. The individual will be responsible for PV Operations as well as PV analytical work.
Job Responsibilities
* Perform oversight tasks of daily study-specific activities including case processing, SAE reconciliation, study set up, query management, eTMF filing, etc.
* Provide input into and medical review of vendor's narratives for quality and completeness and ensure timely submission of expedited reports
* Represent PV on program/study teams. Liaise with cross-functional personnel to provide advice on safety-related matters to ensure overall compliance and application of appropriate standards and methodologies for safety data collection activities for company sponsored studies
* Facilitate and lead cross-functional safety data review meetings; includes setting agenda, coordinating materials, data presentation, and documentation
* Review and update or develop (as needed) Safety Management Plans and other Safety level documents related to product safety. Ensure that the activities of these plans are being met
* Lead effective vendor management strategies to proactively identify operational risks and issues and ensure inspection ready documentation of oversight. Assist with study specific inspection and audit requests related to PV Operations
* Review and provide PV input for development of protocols, IBs, ICFs, CSRs, and other relevant study documents
* Lead authoring for aggregate safety reports (e.g., DSURs)
* Lead efforts related to ad hoc and routine signal evaluation
* Ensure identified quality and compliance metrics are being met and work closely with company Quality department to identify and manage quality issues related to PV
* Draft, contribute to, and maintain the PV departmental SOPs, policies, and work instructions as applicable
* Other duties as assigned
Qualifications
* Bachelor's level degree in nursing, pharmacy, or other health care related field
* 8+ years in pharmacovigilance/drug safety experience in the pharmaceutical/biotech industry setting
* Experience in both PV Operations and PV analytical work (e.g., signaling, aggregate report authoring)
* Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical/pharmaceutical information
* Experience with investigational drug safety is desirable
* Experience with gene therapy and/or mRNA products is a plus
* Thorough understanding of the drug development process and context applicable to safety surveillance activities in clinical trials
* Independently motivated, detail oriented, and excellent problem-solving ability
* Experience with vendor management
* Strong understanding of all relevant global PV regulations and global industry practices
-
Boston, MA, United States Xenon Pharmaceuticals Inc. Full timeDirector/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, developing, and commercializing innovative therapeutics to improve the lives of...
-
Boston, United States Xenon Pharmaceuticals Inc. Full timeWho 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 looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Boston, United States Xenon Full timeWho 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 looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Director, Pharmacovigilance Operations
2 months ago
Boston, MA, United States Tango Therapeutics Full timeCompany 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...
-
Director, Pharmacovigilance
4 weeks ago
Boston, United States Ironwood Pharmaceuticals, Inc. Full timeIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or...
-
Director, Pharmacovigilance and Drug Safety
1 week ago
Boston, United States Xenon Pharmaceuticals Inc. Full timeWho 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 looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Boston, United States HireMinds Full timeDirector/Sr. Director, Pharmacovigilance, Vaccine SafetyBoston, MAOur client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will oversee signal and PV life-cycle management and will be involved in a broad variety of PV and clinical safety activities.This is a full-time...
-
Boston, United States HireMinds Full timeDirector/Sr. Director, Pharmacovigilance, Vaccine SafetyBoston, MAOur client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will oversee signal and PV life-cycle management and will be involved in a broad variety of PV and clinical safety activities.This is a full-time...
-
Director, Pharmacovigilance and Drug Safety
1 week ago
Boston, United States Xenon Full timeWho 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 looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Director, Pharmacovigilance
2 months ago
Boston, MA, United States Ironwood Pharmaceuticals Full timeIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or...
-
Head of Pharmacovigilance Operations and Compliance
2 months ago
Boston, MA, United States Tango Therapeutics Full timeCompany 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...
-
Boston, MA, United States Xenon Pharmaceuticals Inc. Full timeDirector, 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, and commercializing innovative therapeutics to improve the lives of people living...
-
Director, Head Pharmacovigilance, Vaccine Safety
4 weeks ago
Boston, United States HireMinds LLC Full timeOur vaccine client base in Boston, MA is looking to add a Director, Head Pharmacovigilance, Vaccine Safety to their team (CONTRACT/REMOTE)! The ideal candidate will oversee signal and PV life-cycle management and will be involved in a broad variety of PV and clinical safety activities. This contract role will be full-time/40 hours/week and may have the...
-
Boston, United States Xenon Pharmaceuticals Inc. Full timeSenior 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 commercializing innovative therapeutics to improve the lives of people living with neurological and...
-
Boston, United States Xenon Pharmaceuticals Inc. Full timeWho 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 looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Boston, MA, United States Xenon Pharmaceuticals Inc. Full timeSenior 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 commercializing innovative therapeutics to improve the lives of people living with...
-
Boston, United States Xenon Full timeWho 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 looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Medical Director, Clinical Safety Physician
2 weeks ago
Boston, United States Klein Hersh Full timeCurrently our client employees have the opportunity to directly impact global health through COVID-19 vaccine development and post-authorization global administration, and the portfolio is poised to deliver in other important therapeutic areas with unmet medical need. The Clinical Safety group ensures the safety use of our vaccines and therapeutics through...
-
Senior Medical Director, Global Drug Safety
4 weeks ago
Boston, United States Alexion Pharmaceuticals, Inc. 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...
-
Senior Medical Director, Global Drug Safety
4 weeks ago
Boston, United States Alexion Pharmaceuticals, Inc. 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...