| Job List |
| Job ID: |
PCR-05068-9 - Drug Safety Analyst |
| Description: |
Educational Requirements
BS Computer Science or MS equivalent
Years of Experience
2-4 year
Technical Skills
In-depth understanding of FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs; In-depth understanding of ICH guidelines; Oracle databases and PLSQL programming; Thorough understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements; Report generation using Cognos ReportNET and Crystal; Excellent verbal and written communication skills. Understanding of MedDRA and WHO-Drug principles and hierarchy is a plus.
Description
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Salary: 75-95K,
Job Type: Permanent,
Total Exp: 2-4 Yrs,
Start Date: ASAP,
Location: Stamford, CT |
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| Job ID: |
TB-01158-9 - Drug Safety Physician |
| Description: |
Position Summary
' Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products.
' Conduct medical and scientific pharmacovigilance review of:
o Literature Reports including epidemiological background research
o Clinical trial reports
o Study protocols
o Post-marketing ADR reports
o Case files, narratives, coding, causality and expectedness assessment
' Conduct ongoing safety surveillance and signal detection/analysis, including independent analysis of safety risks.
' Provide medical guidance to Drug Safety Associates and others in medical aspects of drug safety.
' Provide medical input in all required safety reports, such as, but not limited to, Periodic Safety Update Reports, Clinical Expert Statement, Investigator notification letters.
' Review all assigned documents for scientifically relevant issues involving drug safety.
' Function as pharmacovigilance representative/safety leader/senior technical lead for Proposal Development Team and/or client meetings, or on trial projects.
' Provide medical advice and support for the safety component of feasibility studies.
' Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products.
' Provide support to peers, marketing activities, and clients as needed.
' Review and sign off on technical documents written with respect to medically relevant matters with particular attention to those relating to drug safety
' Maintain up-to-date knowledge of projects by attending Professional Society Meetings.
Experience:
Background and Skills
' M.D. required, with current medical license
' Experience in clinical medicine (general or specialist qualifications), which is expected to be kept up to date
' One to two years of pharmaceutical industry experience is desirable but not required.
' Clinical Research (Good Clinical Practices) or Pharmacovigilance knowledge /qualifications
' Knowledge of drug safety and the drug development process
' Client focused approach to work
' Good interpersonal skills
' Good verbal / written communication and presentation skills
' Computer skills
' Good time management skills
' Ability to keep current with professional and pharmacovigilance regulations and knowledge
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Salary: 160-200k,
Job Type: Permanent,
Total Exp: 1-2 Yrs,
Start Date: ASAP,
Location: Waltham, MA or Durham, NC |
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| Job ID: |
PCR-05068-10 - Drug Safety Specialist II |
| Description: |
Job Description
Responsible for providing support and assistance in Drug Safety & Pharmacovigilance functions in support of MannKind's objectives and goals including, but not limited, participating in the triage proces of incoming adverse event cases to ensure timely and effective assessment and evaluation
Track and log serious adverse events received from Investigator Sites or CRO's
Ensure that expedited reports are processed and sent to the Regulatory Affairs Department within established timelines
Assist in the distribution of safety reports to investigators
Assist in the drafting of the analysis of similar events and generate "similar events" search and "reviously submitted" line liestings
Review SAE's received from Investigator Sites/CRO's to ensure completeness and accuracy of the SAE information
Query the investigator site/CRO for clarifications and/or missing data as follow up on SAE information
Reconcile SAE's contained in the Clinical Trials Database and the Safety Database
Resolve database discrepancies and end of study reconciliation
Write and review draft SAE narrative
Code adverse events and medical history using the MedDra dictionary and drugs using the WHO-DRL dictionary when applicable
Participate in project/protocol meetings and in meetings with CRO's
Assist in the writing or review of study protocols, informed consents, study reports, investigator brochures, and other safety reports, i.e. annual report to the IND, ISS and assist in safety -related training for clinical operations
Required Skills
Bachelor's Degree with 6+ years of pre-marketing drug safety experience or an equivalent combination of training and experience. RN, RPh, PharmD preferred, but not required
Proficiency with Microsoft office products including Word, Excel, MedDra and WHO-DRL coding experience required
Working knowledge of drug safety databases, i.e., Argus and working knowledge of Code of Federal Regulations regarding drug safety required
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Salary: to 80K,
Job Type: Permanent,
Total Exp: 6+ Yrs,
Start Date: ASAP,
Location: Paramus, NJ |
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| Job ID: |
TB-08287-1 - Global Head Pharmacovigilance Operations |
| Description: |
Essential Function
The Global Head of Pharmacovigilance (PPV) will provide leadership for the global PPV Operations organization. This involves input into strategy, management, business and market development for the Global PPV Operations organization. The Global Head of PPV Operations will further be responsible for quality and compliance of world-wide PPV Operations, as well as for people, process and technology support of Operations objectives. The Global Head of PPV Operations will act on behalf of the entire PPV organization and for all aspects of PV, including deputizing for the Global Head of PPV in internal and external meetings. The Head of PPV Operations is expected to provide high-caliber Pharmacovigilance consulting to internal and external stakeholders and clients.
Key Accountabilities
• Leadership of the Global PPV Operations organization
• Responsible for global integration and alignment of PPV Operations
• Review and development of PPV Operations service offering
• Responsible for quality and compliance of PPV Operations group
• Overall oversight of PPV Operations processes and procedures, including continuous improvement
• Directly influence, jointly with site heads of Medial Services, the strategy direction and resource allocation
• Lead the training for PPV Operations group
• Market and business development on behalf of the entire PPV organization
• Input into PPV business plan, development, budgets, general and growth strategy, including global expansion
• Provide support for marketing activities as requested
• Development of market opportunities
• Technical experts for all aspects of PV for internal and external stakeholders
• Provide medical PV expertise to clients and internally as requested
• Contribute PV medical expertise to routine tasks of PPV Operations
• Train and mentor supervise PPV Operations staff, and Safety Physicians/Medical Monitors
• Public representation of the PPV organization, including attendance and presentations at international conferences
• PV Consulting and Risk Management
• Work closely with colleagues in Medical Services Business Operations and Medical and Drug Safety Managers on PV proposals and projects
• Support Medical Monitors as required
• Provide medical expertise and training to other personnel, as required
• Maintain a current medical license.
• Keep current with professional and PV, and therapeutic area knowledge
Skills
• Excellent knowledge of clinical, scientific and medical aspects of PV
• Excellent knowledge of ICH, CIOMS and drug safety regulations in North America, Europe, Japan, Australia. Good working knowledge of PV regulations in all other regions, including Asia and Latin America.
• Good knowledge of the pharmaceutical and biotechnological world-markets
• Senior level leadership skills
• Senior management skills, including performance management and budgeting
• Personal qualities – ability to gain trust and confidence with a variety of clients as well as within , managerial courage, action oriented and resilience I a fast-paced and rapidly changing environment
• Good general business/operational skills
• Good influencing and negotiating skills
• Excellent communicator
Education
• Medical Degree, and specialist recognition in clinical medicine
• Post-graduate qualifications
• International management experience in PV
Language Skills
• Fluent English
Minimum Work Experience
• 10+ years in PV or related clinical, medical or scientific areas
• International line management experience
• International business and client experience
• Substantial clinical career, preferably on senior level
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Salary: 225K,
Job Type: Permanent,
Total Exp: 10+ Yrs,
Start Date: ASAP,
Location: Boston, MA |
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| Job ID: |
RG-11267-5 - Senior Medical Safety Associate |
| Description: |
The successful candidate will have demonstrated capabilities and sufficient training and experience to oversee and implement a patient safety registry and the collection, recording, and organization of post marketing adverse experiences for an orphan drug. He or she will receive this information rom an experienced call center group. She or he will work closely with the Senior Director Medical Safety and the Chief Medical Safety Officer to organize and interpret these safety data. Appropriate follow-up with the patient and/or the patient?s physician will be required.
He or she will also be responsible for the creation of required regulatory communications, generating periodic report listings, and summarizing the safety experience on a periodic basis. The candidate should be able to devise and follow appropriate operating procedures to conduct this effort in a manner consistent with Good Clinical Practice. She or he will conduct periodic literature reviews of the safety of the subject drug(s) to include ith the periodic reports.
Additional responsibilities may include gaining experience with the organization and interpretation of safety data from clinical trials and ollection and interpretation of serious adverse experiences.
Relocation Plan Available. |
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Salary: to 110k,
Job Type: Permanent,
Total Exp: 4+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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