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Drug
Safety Analyst
A pharmaceutical company located in Connecticut is seeking
a Drug Safety Analyst for the receipt and data entry
of adverse event reports following Standard Operating
Procedures and Working Practice Documents to ensure
compliance with global safety regulations, corporate
and regulatory guidance documents, and corporate policies.
Principal Accountabilities:
- Assess, process, and data enter all case types to
meet compliance requirements
- Identify adverse events, seriousness, listedness,
and labeledness for case assessment; review additional
incoming information to determine reportability
- Perform all appropriate coding
- Draft initial narrative, with use of auto narrative
- Complete initial and follow-up narratives
- Determine follow-up requirements and recommend follow-up
type (phone call, letter, etc.) and formulate and generate
queries
- Interact with internal and external groups on safety
reports
- Work on highest priority or assigned cases using Workflow
Management System; use daily Compliance report
- Perform own QC of reports for regulatory submission
- Perform reconciliation of clinical SAE's
Requirements:
- 1 - 3 years of relevant experience in a pharmaceutical
company or clinical environment required.
- RN, BSN, Nurse Practitioner, Pharmacist, Physician
Assistant or related degree required, or Associates
degree in a relevant field with commensurate Drug Safety
experience
- Drug Safety experience / exposure preferred.
Skills required:
-Data entry and computer skills
- Proficiency with basic MS Office applications
- Familiarity with scientific terms and medical terminology
- Written and verbal communication skills; interpersonal
skills
- Organization skills; analytical thinking
- Time management and ability to prioritize workload
- Quality orientation: attention to detail, accuracy
Preferred skills:
- Detailed understanding of safety processes
- Experience with Argus Safety
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Senior
Drug Safety Analyst
A pharmaceutical company located in Connecticut is seeking
a Senior Drug Safety for the receipt and data entry
of adverse event reports following Standard Operating
Procedures and Working Practice Documents to ensure
compliance with global safety regulations, corporate
and regulatory guidance documents, and corporate policies.
PRINCIPAL ACCOUNTABILITIES
- Assess, process, and data enter all case types to
meet compliance requirements
- Identify adverse events, seriousness, listedness,
and labeledness for case assessment; review additional
incoming information to determine reportability
- Perform all appropriate coding
- Draft initial narrative, with use of auto narrative
- Complete initial and follow-up narratives
- Determine follow-up requirements and recommend follow-up
type (phone call, letter, etc.) and formulate and generate
queries
- Interact with internal and external groups on safety
reports
- Work on highest priority or assigned cases using Workflow
Management System; use daily Compliance report
- Perform own QC of reports for regulatory submission
- Perform reconciliation of clinical SAE's
- Assist with review of scientific literature articles
when required
- Assist with advanced case processing activities (merging
cases, etc.)
- Assist in receiving and documenting incoming calls
and performing follow-up (AE and PC)
- Participate in departmental training
- Represent Safety in internal and external meetings
- Produce periodic reports
- Act as Mentor / Subject Matter Expert to Analysts
- Assume project responsibility as assigned
Education/Experience Requirements:
- RN, BSN, Nurse Practitioner, Pharmacist, Physician
Assistant or related degree required, or Associates
degree in a relevant field with commensurate Drug Safety
experience.
- 2 - 4 years of experience in a pharmaceutical company
or clinical environment required.
- Drug Safety experience required.
Skills required:
- In-depth understanding of FDA and international regulations
- Data entry and computer skills
- Proficiency with basic MS Office applications and
experience with relational safety database
- Working knowledge of scientific terms and medical
terminology
- In-depth understanding of MedDRA
- Excellent written and verbal communication skills;
interpersonal skills
- Organization skills
- Ability to analyze and summarize information
- Time management and ability to prioritize workload
- Quality orientation: attention to detail, accuracy
- Ability to train and coach others
- Detailed understanding of safety processes
- Experience with Argus Safety
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Medical
Director
Education: Medical Doctor (M.D.) o MD from an accredited
medical school with US licensure and/or board certified.
No exceptions.
A major branded pharmaceutical company located in New
Jersey seeks an Medical Director to oversee the medical
review of Periodic Safety Update Reports for the EU
and FDA. US IND and NDA alert reports and clinical trial
and post marketing adverse events. Adverse events and
safety reports received and prepared by DSS. Advertising
materials for marketed US product(s). Respond to queries
from internal and external Health Care Professionals.
Manage follow-up activities for post-marketing AE reported
by external Health Care Professionals, as needed. Identify,
develop and implement timely Medical Affairs strategies
with strong scientific approach and reliable clinical
judgment to create enhanced value for relevant products
Strive to gain quality data from scientific projects
for access in the worldwide markets (product profiling,
reimbursement, funding, promotional use). Work to develop
and maintain strong relationships with pharmaceutical
business partners, relevant scientific societies and
opinion leaders
Industry experience with PSUR's from the standpoint
of reviewing, interpreting and evaluating aggregate
data; Demonstrated excellence in oral and written English
communication; Ability to analyze, edit and review clinical
medical data used to prepare FDA; MedWatch & CIOMS
AE reports for medical content and International exposure.
You must be a proven leader and have supervisory experience.
Excellent communication and presentation skills.
Experience in interacting with key opinion leaders and
advisory boards. Ability to analyze complex scientific
concepts. Excellent project and time management, strategic
planning skills. Good team player interacting with different
internal departments in research and business. Problem
solver with high degree of initiative and independence.
Excellent computer skills; Ability to prioritize and
handle multiple projects simultaneously with tight deadlines
and high pressure; Ability to quickly learn products;
Ability to make decisions.
Education: Medical Doctor (M.D.) o MD from an accredited
medical school with US licensure and/or board certified.
No exceptions.
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Associate Medical Director
A major branded pharmaceutical company located in New
Jersey seeks an Medical Director to oversee the medical
review of Periodic Safety Update Reports for the EU
and FDA. US IND and NDA alert reports and clinical trial
and post marketing adverse events. Adverse events and
safety reports received and prepared by DSS. Advertising
materials for marketed US product(s). Respond to queries
from internal and external Health Care Professionals.
Manage follow-up activities for post-marketing AE reported
by external Health Care Professionals, as needed. Identify,
develop and implement timely Medical Affairs strategies
with strong scientific approach and reliable clinical
judgment to create enhanced value for relevant products
Strive to gain quality data from scientific projects
for access in the worldwide markets (product profiling,
reimbursement, funding, promotional use). Work to develop
and maintain strong relationships with pharmaceutical
business partners, relevant scientific societies and
opinion leaders
Industry experience with PSUR's from the standpoint
of reviewing, interpreting and evaluating aggregate
data; Demonstrated excellence in oral and written English
communication; Ability to analyze, edit and review clinical
medical data used to prepare FDA; MedWatch & CIOMS
AE reports for medical content and International exposure.
You must be a proven leader and have supervisory experience.
Excellent communication and presentation skills.
Experience in interacting with key opinion leaders and
advisory boards. Ability to analyze complex scientific
concepts. Excellent project and time management, strategic
planning skills. Good team player interacting with different
internal departments in research and business. Problem
solver with high degree of initiative and independence.
Excellent computer skills; Ability to prioritize and
handle multiple projects simultaneously with tight deadlines
and high pressure; Ability to quickly learn products;
Ability to make decisions.
Education: Medical Doctor (M.D.) o MD from an accredited
medical school with US licensure and/or board certified
or US Educated not licensed.
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Executive Director, Pharmacovigilance
Pharmaceutical company located in Florida is seeking
an Executive Director, Pharmacovigilance to provide
strategic direction for growth and advancement of key
functional areas.
Position Summary:
The Executive Director (ED) will oversee the operations
of the pharmacovigilance (PV) department, with responsibilities
for both clinical safety and post-marketing surveillance;
functions include pharmacovigilance operations, data/case
management, and medical review. The ED will be responsible
for ensuring appropriate assessments and analysis of
safety data, adverse event (AE) reporting, and for establishing
and maintaining processes for continuous evaluation
of the safety of the investigational and marketed products.
The ED will liaise with Product Realization (PR) and
Lead Optimization (LO), third party vendors, and business
partners both domestically and internationally, to assure
associated agreements are developed, implemented and
maintained for marketed and investigational products.
The ED will, in conjunction with Regulatory Affairs
(RA), assure compliance with reporting requirements.
The ED will be responsible for communicating information
cross-functionally and to senior management teams.
Position Scope:
PV for all products (investigational and marketed),
and products for which a safety agreement is in place
with another company or vendor, domestically and internationally.
This position requires substantial knowledge of GCPs,
US, ex-US and ICH regulatory
requirements for pharmacovigilance of marketed drug
products. Global safety medical expert for all assigned
marketed drugs or devices.
Experience:
MD degree with minimum 10 years of experience in pharmacovigilance
in the pharmaceutical and/or biotechnology and/or CRO
setting. Five years direct personnel and functional
management experience. Strong knowledge of worldwide
safety regulations for marketed and investigational
products. Experience with risk assessment/management
strategies. Demonstrated high-level strategic thinking.
Demonstrates initiative, ability to formulate investigative
plan, ability to work under pressure. Ability to generate
creative solutions for complex problem; deal with a
variety of concrete variables in situations where limited
standardization may exist.
Strong negotiation skills. Highly self-motivated and
able to work effectively with minimum supervision. Excellent
management, motivational, presentation, teamwork and
interpersonal skills. Strong leadership skills, ability
to mentor and work effectively in multi-functional teams.
Demonstrated project management skills and experience
in conflict resolution. Excellent analytical skills,
including the demonstrated ability to evaluate and interpret
data and to communicate complex clinical issues in a
scientifically sound and understandable way both to
internal and external customers including worldwide
regulatory authorities. Understanding of the medical
and scientific principles associated with the administration
of the products.
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