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Drug Safety Associate
1 week 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 ...
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Drug Safety Specialist
2 weeks 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 ...
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Drug Safety Specialist
3 weeks 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 ...
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Hybrid Drug Safety Specialist
2 weeks ago
Staffmark Group Waltham, United StatesHybrid- 3 days minimum will be onsite. · 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 but not limited to the receipt, evaluation, reviewing and r ...
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Morphic Holding, Inc. Waltham, United States· About Morphic Therapeutic · Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaborati ...
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Dyne Therapeutics, Inc. Waltham, United StatesCompany 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 thera ...
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BioSpace Waltham, United StatesJob Details · 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 olig ...
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Drug Safety Associate
2 weeks 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/ ...
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Sr. Manager/Associate Director, Drug Safety
2 weeks ago
Viridian Therapeutics Inc. Waltham, United States· At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driv ...
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MURAL ONCOLOGY PLC Waltham, United StatesThe Mural team brings together oncology expertise and passion to make an impact on patients' lives. We are seeking a highly motivated individual to join our team. · Overview · The Executive Medical Director serves as the functional head of DSPV, and is accountable for the managem ...
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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 ...
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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 ...
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Medical Director, Drug Safety
2 weeks 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 ...
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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 ...
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Medical Director, Drug Safety
6 days 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 ...
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Medical Director, Drug Safety
1 week 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 ...
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Medical Director, Drug Safety
2 weeks 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 ...
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Medical Director, Drug Safety
1 week ago
LeadingAge 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 t ...
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Medical Director, Drug Safety
3 days ago
Apex Systems Cambridge, United StatesMedical Director, Drug Safety & Pharmacovigilance Location:Cambridge MA (Onsite)Science/ Focus:CRISPR/Cas9Therapeutic 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 ...
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Medical Director, Drug Safety
1 week ago
Apex Systems Cambridge, United StatesJob#: · Job Description: · Medical 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 d ...
Director/ Senior Director/ Executive Director of Pharmacovigilance and Drug Safety - Waltham, MA, United States - Stratacuity
Description
Sr. Director/Executive Director PV and Drug Safety Location: Waltham, MA (Onsite) Therapeutic Area: Immuno-Oncology Job Overview: This role will be responsible for managing drug safety data, authoring safety documents, organizing meetings, collaborating with cross-functional teams, ensuring compliance with global drug safety regulations, and providing vendor oversight.
Primary Job Requirements:
Collaborate with and oversee the work of CROs involved in ICSR management and reporting to business partners.
Provide subject matter expertise in regulations for case processing and assessment of adverse events.
Perform quality reviews of draft narratives and analysis reports received from CROs.
Support signal detection and risk management activities, including the organization of Safety Management Team meetings and preparation of safety documentation
Primary Job Requirements:
Healthcare professional degree required, with preference given to candidates with early oncology clinical safety experience and biotech industry background.
10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines.
Demonstrated proficiency in drug safety databases (e.g., Argus), electronic data capture systems, and coding with MedDRA and WHO Drug dictionary.
Strong track record of overseeing global safety activities, managing multiple projects concurrently in a fast-paced environment, and effectively collaborating with cross-functional teams.
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. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. 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. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable 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.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable 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 our Employee Services Department at or
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