- Manage safety surveillance for assigned products and collaborate with PV scientists and other stakeholders
- Conduct analyses of safety trial data. Ensure adequacy of summarizing and handling of adverse events for investigational and/or marketed Biogen products including decisions on seriousness, expectedness, and causality.
- Provide safety strategic leadership for clinical development programs
- Integrate the safety scientific component to building a strategic framework for clinical development plans.
- Develop and maintain relationships with counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, and Worldwide Medical.
- Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities.
- MD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred
- Minimum 2+ years experience in the pharmaceutical industry or clinical care setting.
- Preferably has prior experience in pharmacovigilance or clinical development.
- Knowledge of pre- and post- marketing US and EU regulations
- Strong communication skills, scientific acumen, and the ability to work across the development functions are key traits for a Medical Director in this group.
- Capacity and willingness to work effectively across disease areas
- The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills
-
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 ...
-
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/ ...
-
Medical Director, Drug Safety
6 days 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
6 days 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: 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
6 days 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
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 ...
-
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 ...
-
Medical Director, Drug Safety
3 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
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 ...
-
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 ...
-
Medical Director, Drug Safety
2 weeks 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
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 ...
-
Medical Director, Drug Safety
2 weeks 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
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 ...
-
Medical Director, Drug Safety
3 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
2 weeks 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, ...
-
Medical Director, Drug Safety
1 day 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 ...
-
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 ...
-
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 ...
Medical Director, Drug Safety - Cambridge, United States - Biogen
Description
Job Description
Job DescriptionJob 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 investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
Responsible for keeping upper management informed of safety issues and may work with clinical programs as a medical advisor. May represent Biogen Drug Safety and Risk Management at internal and external meetings. The MD can be appointed as the Global Safety Officer for a specific compound/product.
What You'll Do
Who You Are
You demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through the life cycle.
The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities.
QualificationsRequired Skills
#LTD-1
Additional InformationWhy Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
