-
Drug Safety Associate
2 days ago
Talent Groups Waltham, United States3-5 years of experience in drug safety, pharmacovigilance, or clinical safety within the pharmaceutical or biotechnology industry. · - Knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH). · - Strong analytical skills with the ability to critical ...
-
Drug Safety Associate
1 week ago
The Fountain Group LLC Cambridge, United StatesCurrently seeking a Drug Safety Associate for a prominent client of ours. This position is located in Cambridge, MA. Details for the position are as follows: · Job Description: · Shift: Monday-Friday (hybrid depending on what is needed in the project) · Pay: $50-$59.05/ ...
-
Medical Director, Drug Safety
1 week ago
Stratacuity Cambridge, United StatesMedical Director, Drug Safety & Pharmacovigilance Location: Cambridge MA (Onsite) Science/ Focus: CRISPR/Cas9 Therapeutic Area: Rare Disease Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a un ...
-
Medical Director, Drug Safety
3 days ago
Biogen Cambridge, United StatesJob Description · Job DescriptionJob Description · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clin ...
-
Medical Director, Drug Safety
1 week ago
Stratacuity: Proven Scientific Placement Cambridge, United StatesLocation: Cambridge MA (Onsite) · Science/ Focus: CRISPR/Cas9 · Therapeutic Area: Rare Disease · Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implement ...
-
Medical Director, Drug Safety
1 week ago
Biogen Idec Cambridge, United StatesCompany DescriptionJob Description · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, th ...
-
Medical Director, Drug Safety
1 week ago
Biogen Cambridge, United StatesCompany Description · Job Description · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials ...
-
Medical Director, Drug Safety
2 weeks ago
Stratacuity Cambridge, United StatesLocation: Cambridge MA (Onsite) · Science/ Focus: CRISPR/Cas9 · Therapeutic Area: Rare Disease · Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implem ...
-
Medical Director, Drug Safety
5 days ago
Apex Systems Cambridge, United StatesMedical Director, Drug Safety & Pharmacovigilance · Location:Cambridge MA (Onsite) · Science/ Focus:CRISPR/Cas9 · Therapeutic Area:Rare Disease · Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, provi ...
-
Medical Director, Drug Safety
3 days ago
Biogen Cambridge, United StatesJob Description · You could be just the right applicant for this job Read all associated information and make sure to apply. · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including ...
-
Medical Director, Drug Safety
4 days ago
Biogen Cambridge, United StatesJob Description · The following information aims to provide potential candidates with a better understanding of the requirements for this role. · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigationa ...
-
Medical Director, Drug Safety
2 weeks ago
Stratacuity: Proven Scientific Placement Cambridge, MA, United StatesScience/ Focus: CRISPR/Cas9 · Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the manag ...
-
Medical Director, Drug Safety
1 week ago
Biogen Idec Cambridge, MA, United StatesJob DescriptionAbout This Role The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification, and in ...
-
Medical Director, Drug Safety
1 week ago
Biogen Cambridge, United States Full timeJob Description · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification, ...
-
Drug Safety Specialist
1 week ago
Queen Consulting Group, Inc. Waltham, United StatesOur client is seeking a Drug Safety Specialist with clinical experience. The Drug Safety Specialist will have primary responsibility for the following: Case Processing (CT/ PM) - 50% Responsible for the processing adverse event reports that include b Safety Specialist, Drug, Spec ...
-
Drug Safety Specialist
1 week ago
GForce Life Sciences Waltham, United StatesDuration: 6-month contract · Location: Onsite in Waltham - 3 days onsite, 2 days wfh · Start 2 weeks from an offer · Responsibilities: · Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adver ...
-
Sr. Drug Safety Specialist, Compliance
1 week ago
Proclinical Cambridge, United States ContractSenior Drug Safety Specialist, Compliance - Contract - Cambridge, MAProclinical is on the lookout for a dedicated and experienced professional to fill the role of Drug Safety and Pharmacovigilance Compliance Specialist. This is a contract position located in Cambridge, MA. · Prim ...
-
ONO PHARMA USA Cambridge, United StatesThis is a Senior Manager level role that oversees the effective delivery of and continued evolution of Pharmacovigilance (PV) activities related to organization's clinical development programs. · Develops and designs pharmacovigilance processes and procedures to ensure complianc ...
-
Associate Medical Director, Drug Safety
1 week ago
Biogen Cambridge, United StatesCompany Description · Job Description · What you'll do: · The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials ...
-
Associate Medical Director, Drug Safety
6 days ago
Biogen Idec Cambridge, United StatesCompany DescriptionJob Description · What you'll do: · The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, i ...
Medical Director, Drug Safety - Cambridge, United States - LeadingAge
Description
Location:
Cambridge MA (Onsite)
Science/ Focus:
CRISPR/Cas9
Therapeutic Area:
Rare Disease
Job Overview:
This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
Primary Job Responsibilities:
Collaborate with the clinical development team to develop and implement a comprehensive safety surveillance strategy for clinical trials across different platforms.
Lead a cross-functional project focusing on the development of guidance for the long-term safety assessment of gene-editing products, ensuring compliance with regulatory requirements and best practices.
Primary Job Requirements:
MD with 10+ years of experience in drug development and drug safety/pharmacovigilance, with specific expertise in clinical oncology, immunology, or genetics
Strong knowledge and hands-on experience with good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines.
Proven track record of leading and authoring safety guidance documents, position papers, and safety sections of IND or BLA submission dossiers.
Prior experience in gene therapy products or biologics, demonstrating the ability to navigate the unique challenges of pharmacovigilance in these areas.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member.
PROVEN SCIENTIFIC PLACEMENT
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
#J-18808-Ljbffr