Pharmacovigilance Assessor Jobs
By Aequor At South San Francisco, CA, United States
Understand the vendor management framework and translate the requirements into reporting deliverables
Project Management responsibilities, including the development and management of detailed project schedules and scope of work
Education, Experience, and Other Requirements:
Escalates compliance risks or issues to management when identified
Demonstrates expertise in computer skills and database experience (i.e Microsoft Office Suite and Google Applications ) (Preferred)
Familiarity with project management software tools, methodologies, and best practices
Sr Director, Pharmacovigilance Qa
By Insmed Incorporated At , Bridgewater, 08807 $200,000 - $280,000 a year
Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
Requires solid experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing.
Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.
Strong knowledge and understanding of drug and device FDA, EU and ICH regulations, pharmacovigilance regulations/processes and HA inspection procedures is required.
Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice.
Unique offerings of pet, legal, and supplemental life insurance
Senior Pharmacovigilance Specialist Jobs
By Ortho Dermatologics At , Philadelphia, 19133, Pa
Analyze metrics for critical drug safety processes to ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed.
3+ years of Pharmacovigilance experience MANDATORY
Working knowledge of scientific terms and medical terminology
Excellent oral and written communication skills
Excellent interpersonal skills and willingness to work in a team environment
To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/379301a79c224eae9f25e08c7426cedde0ec4807) .
Pharmacovigilance Senior Director Jobs
By Generate:Biomedicines At United States
Line management (direct reports) experience is strongly preferred.
Advises senior management on the PV strategy and pathway to achieve drug candidate strategic milestones and objectives. .
Authors, contributes to and/or oversees the preparation of aggregate safety reports and risk management plans (RMPs).
Experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
Ensures the team and the assigned work comply with established practices, policies and processes and any regulatory or other requirements.
MD / DO degree or equivalent with 6+ years' relevant experience in pharmaceutical or biotech drug development.
Pharmacovigilance Scientist Jobs
By Mersana Therapeutics At Cambridge, MA, United States
Excellent interpersonal, relationship management, and decision-making skills.
Provide support to Product Safety Lead in activities relating to monitoring and management of emerging safety profiles for assigned product(s).
Prepare materials (Slides, etc.) in preparation for safety committees such as Safety Management Team and DSMBs.
Experience working on oncology trials.
A working knowledge of clinical and drug safety databases.
Experience using analytics tools (Spotfire, Tableau, etc.).
Scientist Jobs
By Premier Life Sciences LLC At Farmingville, NY, United States

Must Haves: Chemical Background, Pharmaceutical background (No Medical Device) make sure they have experience with highlighted areas

Performs physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer

Pharmacovigilance Specialist- Case Review
By TotalMed, Inc. At United States
Bachelor's degree and 2 years of directly related experience OR Associate's degree and 6 years of directly related experience
Conduct follow up activities with HCP and patients.
Complete assigned reports and provide support for vendor related queries relating to ICSR processing.
Position Title – Pharmacovigilance Specialist
Contract Length – 6 months
Pharmacovigilance Specialist Jobs
By SPECTRAFORCE At United States
Below is a brief introduction of SPECTRAFORCE, the benefits we offer, and the disclaimers:
• Masters or higher degree – Medical-related experience
• Minimum 3+ years of experience
• Base MS Microsoft Office experience
•Previous experience with medical validations/ reviews/ adverse events
• Must have clinical experience/ medical understanding
Remote: Pharmacovigilance Scientist (233486) Jobs
By Black Diamond Networks At United States

Oncology (Solid Tumor Exp Preferred)

Scientist Jobs
By Talentmark At Miami, FL, United States
Full-time, permanent position located in Miami.
• Open to BSc or MSc qualified
• Highly motivated and hard-working individuals who will thrive in a collaborative and fast-paced work environment.
• Excellent spoken and written communicator.
It is essential you have the right to work in the US.
If you are interested in finding out more about this position, please contact Amy Lloyd at [email protected]
Scientist - Cheminformatics Jobs
By BioSpace At Redwood City, CA, United States

Ph.D. And No Experience Required

Uniquely Interesting Work, Life-changing Careers

Scientist Jobs
By InVivo Biosystems At Eugene, OR, United States
Level of role is determined by a combination of education in the biological sciences and relevant experience.
Prior experience with C. elegans and/or zebrafish or similar animal models preferred.
Ability to creatively problem-solve, apply critical thinking skills, and respond to changing goals.
Above-average written and interpersonal communication skills.
Ability to multi-­task, prioritize, work autonomously and manage time effectively.
Experience in industry or commercial laboratory setting preferred.
Pharmacovigilance And Safety Jobs
By McInnis Inc. At Ridgefield, CT, United States
5+ years industry experience in pharmacovigilance/risk management and analysis of safety data.
Provide personnel/resources qualified to meet deliverable expectations as more completely described in the Responsibilities and Deliverables set forth below.
Along with Project Manager, review all timecards and any expense reimbursements for accuracy and adherence with policies.
Clinical Medicine experience with more than 1+ year of patient care required.
Excellent written & verbal communication skills.
Experience performing medical review and assessment of individual case safety reports and expedited reporting required.
Scientist Pharmacovigilance Jobs
By Daiichi Sankyo, Inc. At Basking Ridge, NJ, United States
1 or More Years of PV experience and knowledge of FDA regulations required
Education Qualifications (from An Accredited College Or University)
Bachelor's Degree in nursing, pharmacy, or healthcare related field preferred
Join a Legacy of Innovation 110 Years and Counting!
Team Lead Pharmacovigilance (12-Month Contractor)
By ProductLife Group At United States
Ensure the drafting / revision of all quality documents inherent in the vigilance responsibilities,
Implement a routine PV system meeting all FDA and HHCHC HC requirements,
Promote, maintain, and improve compliance with pharmacovigilance regulatory requirements,
Implement systems to measure compliance with agency regulatory requirements ,
Adequate theoretical and practical knowledge for the performance of pharmacovigilance activities,
Carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports,
Pharmacovigilance Project Coordinator Jobs
By GroupA At United States
Establish a project management plan to summarize the scope of work, deliverables list, master schedule, org chart, quality expectations, etc.
Apply best-in-class project management approaches to support execution.
Track and facilitate the resolution of project risk, issues and manage escalations to the PMO and GPS leadership.
Support program/project managers with project coordination (scheduling meetings, taking minutes, documenting risks/mitigations).
3+ years of biotech/pharmaceutical experience supporting/managing pharmacovigilance related projects is preferred.
Knowledgeable about GVP, GCP, and GxP practices.
Pharmacovigilance Manager Jobs
By Avery Fairbank At United States
• Participate in the development of protocols and plans for the pharmacovigilance department, including risk management strategies.
• Demonstrated experience with safety databases and data entry.
• Proficient in MS Office Suite and familiar with database management.
• At least 5 years of experience in the pharmacovigilance field within the pharmaceutical or biotech industry.
• Strong knowledge of international pharmacovigilance regulations (e.g., FDA, EMA, ICH).
• Ability to manage complex safety cases.
Pharmacovigilance Project Coordinator Jobs
By MSI Pharma At Maryland, United States
Required Project Management Professional (PMP) or Certified Scrum Master (CSM) certification
Establish a project management plan to summarize the scope of work, deliverables list, master schedule, org chart, quality expectations, etc.
Apply best-in-class project management approaches to support execution.
Track and facilitate the resolution of project risk, issues and manage escalations to the PMO and GPS leadership.
Support program/project managers with project coordination (scheduling meetings, taking minutes, documenting risks/mitigations).
3+ years of biotech/pharmaceutical experience supporting/managing pharmacovigilance related projects is preferred.
Remote - Part-Time - Senior Pharmacovigilance Management Consultant
By Beacon Hill Staffing Group At United States
Vendor Management Oversight for pharmacovigilance experience
Previous experience with adverse event reporting systems, FDA and EU drug safety/Pharmacovigilance requirements
Oversee and manage project and steer in the right direction
8+ years of biotech/pharmaceutical experience in Drug Safety/Pharmacovigilance
Experienced in drug safety for a small biotechnology corporation strongly preferred
Experienced with running safety review board / steering committee meetings
Director, Qa Pharmacovigilance (Gvp)
By Exelixis, Inc. At , Alameda, 94502, Ca $189,000 - $268,500 a year
Equivalent combination of education and experience.
Demonstrates strong time-management and organizational ability to creatively analyze and improve processes and consistently produce high quality work.
Understand and interpret regulatory agency policies and guidance as it pertains to GVP requirements.
PhD in related discipline and a minimum of eight years of related experience; or,
Proven technical understanding and application of regulatory agency policies and guidance pertaining to GVP requirements.
Possesses strong written and oral communication skills, with demonstrated ability to translate complex concepts across all levels of the organization.

Are you passionate about patient safety and looking for an exciting opportunity to make a difference? Join our team as a Pharmacovigilance Scientist and help us ensure the safety of our products and the well-being of our patients!

Overview:

A Pharmacovigilance Scientist is responsible for monitoring the safety of pharmaceutical products and assessing the risks associated with their use. They analyze data from clinical trials, post-marketing studies, and other sources to identify potential safety issues and recommend appropriate action.

Detailed Job Description:

The Pharmacovigilance Scientist is responsible for monitoring the safety of pharmaceutical products and assessing the risks associated with their use. This includes analyzing data from clinical trials, post-marketing studies, and other sources to identify potential safety issues and recommend appropriate action. The Pharmacovigilance Scientist will also be responsible for developing and implementing safety surveillance plans, evaluating safety signals, and preparing safety reports. They will also be responsible for providing guidance and support to other departments on safety-related matters.

What is Pharmacovigilance Scientist Job Skills Required?

• Knowledge of pharmacovigilance principles and regulations
• Excellent analytical and problem-solving skills
• Ability to interpret and analyze data
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Proficiency in using computer software programs

What is Pharmacovigilance Scientist Job Qualifications?

• Bachelor’s degree in a relevant field such as pharmacy, medicine, or life sciences
• Master’s degree in a relevant field is preferred
• Relevant experience in pharmacovigilance or a related field
• Certification in pharmacovigilance is preferred

What is Pharmacovigilance Scientist Job Knowledge?

• Knowledge of pharmacovigilance principles and regulations
• Knowledge of clinical trial and post-marketing safety data
• Knowledge of safety signal detection and evaluation
• Knowledge of safety reporting requirements

What is Pharmacovigilance Scientist Job Experience?

• Experience in pharmacovigilance or a related field
• Experience in safety signal detection and evaluation
• Experience in safety reporting

What is Pharmacovigilance Scientist Job Responsibilities?

• Monitor safety of pharmaceutical products
• Analyze data from clinical trials and post-marketing studies
• Develop and implement safety surveillance plans
• Evaluate safety signals
• Prepare safety reports
• Provide guidance and support to other departments on safety-related matters