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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 ...
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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/ ...
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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
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 ...
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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 ...
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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
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
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 ...
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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 ...
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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 ...
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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 ...
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Medical Director, Drug Safety
1 day 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
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 ...
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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 ...
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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, ...
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The Elle Group Boston, MA, United StatesThe 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 · ...
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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 ...
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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 ...
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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 ...
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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 ...
Senior Medical Director, Global Drug Safety - Boston, MA, United States - Alexion Pharmaceuticals
Description
This 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 through leadership of a team of Medical Directors and Safety Scientists.
This global team is accountable for the identification, analyses, assessment, communication and risk management of safety issues arising for the assigned product portfolio across their entire lifecycles.
The jobholder provides medical and drug safety expertise to oversee and lead decision making based on complex risk/benefit evaluation, pharmacoepidemiological or clinical trial data interpretation, risk assessment and risk mitigation.
In this capacity, the jobholder may represent the Global Patient Safety department as a subject matter expert on internal strategic or advisory committees.
The jobholder has significant impact on cross-functional goals, including collaborating with the Clinical & Medical organization to enhance the safe and effective use of Alexion products and with the Commercial Organization to increase the probability of regulatory success.
The Senior Medical Director reports to the Executive Medical Director, Global Patient Safety.You will be responsible for:
Leads, provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned Alexion product portfolio for entire lifecycle (pre and post approval)
Accountable for the following:
Leads a team of Medical Directors, and Safety Scientists in identifying, evaluating and facilitating resolution of safety signals, including effective communication of risk management plansProvides medical and pharmacovigilance expertise to oversee and lead decision making based on complex risk/benefit evaluation, pharmacoepidemiological or clinical trial data interpretation, risk assessment and risk mitigationPartners with internal leaders within Global Patient Safety as well as other Alexion functions and affiliates to deliver integrated pharmacovigilance and risk management support to the Alexion businessLeads Product Safety Management Teams with Medical Directors to support key decision-making, drive evidence–based conclusions and develop pivotal next stepsOversees work carried out on products and/or issues under highest scrutiny from a patient safety or regulatory perspectiveEnsures ongoing and adequate safety surveillance, and timely detection and communication of new safety issues by his/her teamEnsures timely and adequate generation of aggregate reports, regulatory responses and risk management documentation by team, according to international requirements and internal standards.
MD or equivalent degree or a life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experienceSound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problemsThe ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines, for several projects and sub-projects, including oversight of others working on those projectsKnowledge and understanding of GPS deliverables, standards and processesKnowledge and understanding of US and EU safety regulations pre- and post- marketingThe duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:5-7 years relevant safety and risk management experience in the pharmaceutical, biotech or CRO industryRare, Ultra-Rare or Orphan Disease Area experienceStrong verbal and written communication skills including making recommended courses of action to management and/or senior leaders that impact the discipline, department or line, and influences their decisionsExcellent, independent judgment based on knowledge and expertiseStrong personal time-management and project-management skillsMastery of Microsoft Word, PowerPoint and ExcelExpectation of working in the office 3 days a week: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
AstraZeneca embraces diversity and equality of opportunity.We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.#LI-RM1Date Posted06-Mar-2024Closing Date31-May-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.
We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.
Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
SummaryLocation:
US - Boston - MAType: Full time