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Pharmacovigilance Manager Jobs

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
Associate Director / Manager, Pharmacovigilance Qa (Quality Assurance)
By GSK At , Collegeville
Have demonstrated project management skills and management of complex cross-functional activities
Assist in the development, management, and implementation of strategies and initiatives, policies and procedures to support the PV audit program
Be responsible for primary internal customer base including Global Safety, LOCs, Safety Governance, Risk Management, QPPVs, GRA
Expert knowledge of global, regional and national PV regulatory requirements and regulations
Maintain an up-to-date and in-depth knowledge of appropriate national and international PV/GCP legislation and guidelines that affect the business
Maintain an in-depth knowledge of PV processes and procedures
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.).
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)

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!
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.
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.
Scientist Pharmacovigilance Jobs
By Daiichi Sankyo, Inc. At , Basking Ridge, Nj
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
Pharmacovigilance Advisor Jobs
By Kelly At Washington DC-Baltimore Area, United States
Ensure NIH Clinical Center Pharmacy’s policy and procedures are incompliance with requirements by local regulation and the Sponsor.
Interact with IDCU/IVAU managers and Pharmacy QC/QA team.
Eight (8) years of experience in a science related field.
Demonstrates expert knowledge working in the research laboratory environment.
This is a long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
Manager, Pharmacovigilance Quality Assurance
By ABBVIE At , , Il
Project management, interpersonal, and communication skills and ability to work independently and as part of a team
Knowledge of PV regulatory requirements and industry best practices
Participates in and supports PV inspections onsite or remotely to ensure that PV inspections are a success.
Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
5 years of experience in the biopharmaceutical industry or with a regulatory authority
5 – 7 years of experience in Quality Assurance and/or Pharmacovigilance
Rems Pharmacovigilance Operations Lead
By Azurity Pharmaceuticals At Atlanta, GA, United States
Expert knowledge and proven track record of REMS management and operations
Recent Pharmaceutical industry experience with patient services and/or vendor management
Oversight and management of Risk Evaluation and Mitigation Strategies (REMS) day-to-day activities
Liaise with specialty pharmacies to ensure that all REMS requirements and processes are managed and maintained
Manage day-to-day activities of Risk Evaluation and Mitigation Strategies (REMS) program to maintain regulatory compliance
Assess and implement ongoing REMS process and service-related improvements to ensure continuity and patient satisfaction while fostering a positive prescriber experience
Senior Manager, Pharmacovigilance Compliance
By FibroGen, Inc. At United States
Experience in PV quality systems, compliance monitoring, CAPA management, and the development and maintenance of standards and training programs
Experience in PV inspection readiness and management
Collect, compile, monitor, analyze, and report key metrics (compliance, quality, performance) at defined internals per the global compliance management processes
Expert knowledge of FDA, EMA and ICH PV regulations and guidelines
Demonstrated problem-solving and critical thinking skills
Excellent interpersonal, communication, analytical, and organizational skills
Remote: Pharmacovigilance Scientist- (232671) Jobs
By Black Diamond Networks At United States

Job Description Our Client needs an 8+ year Pharmacovigilance Scientist to come in and help with standard PV related work including but not limited to aggregate report writing, PSUR/DSUR and ...