Manager - Pharmacovigilance/Drug Safety
Streffco Consultants, Inc., is an international staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis.
Title: Partner Operations Manager, Study Management Safety Operations Oversight
Job ID: 6729
Industry: Biotech/Pharmaceutical
Unit: Safety and Benefit-Risk Management
Location: Cambridge, MA
Duration: 6 months Contract
Pay Rate Range: Depends on Experience (W-2 all inclusive rate)
Position
Summary:
? Manages pharmacovigilance (PV) operations of global clinical studies by acting as safety operations lead on cross-functional study teams with responsibilities for safety operations throughout study duration.
Key
Responsibilities:
Develops content and oversees delivery of training materials to study teams and investigators.
? Reviews and provides input on documents related to study conduct, including CRO contracts, study protocols, Data Management plans, Case Report Forms, Safety Management Plans and Safety Data Exchange Agreements, were applicable.
? Oversees and participates in SAE reconciliation.
? Implements operational aspects of studies according to associated timelines, including: Global Safety Database set-up, production of safety reporting forms, SUSAR processes, and trial summaries created and maintained for case management team.
? Works cross-functionally with Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others during study set-up, maintenance, and closure.
? Investigates cases requiring Corrective and Preventative Action plans and ensures appropriate actions are taken.
? Initiates and assists with trial-related operational process changes and associated updates of controlled documents and timely communications.
? Acts as subject matter expert on PV study operations during audits/inspections.
? Supports maintenance of PV regulatory compliance for clinical studies.
? Provides case processing back up as needed.
? Occasional travel may be necessary.
Required Skills:
? 5
years in drug safety/pharmacovigilance in pharmaceutical industry setting or the equivalent.
? Experience with interacting with third parties (e.g., contract service providers) preferred.
? Knowledgeable in Pharmacovigilance and GCP legislation required.
? Direct experience in GXP compliant quality systems preferred.
Educational Requirements:
Minimum of Bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required.
Master's or Doctorate level degree in health care related profession preferred.
Please respond by submitting your resume in a Word Document.
(Please include the job title and id# in the subject line)
We will not respond to everyone personally - qualified candidates will be contacted for an interview.
Estimated Salary: $20 to $28 per hour based on qualifications.
Title: Partner Operations Manager, Study Management Safety Operations Oversight
Job ID: 6729
Industry: Biotech/Pharmaceutical
Unit: Safety and Benefit-Risk Management
Location: Cambridge, MA
Duration: 6 months Contract
Pay Rate Range: Depends on Experience (W-2 all inclusive rate)
Position
Summary:
? Manages pharmacovigilance (PV) operations of global clinical studies by acting as safety operations lead on cross-functional study teams with responsibilities for safety operations throughout study duration.
Key
Responsibilities:
Develops content and oversees delivery of training materials to study teams and investigators.
? Reviews and provides input on documents related to study conduct, including CRO contracts, study protocols, Data Management plans, Case Report Forms, Safety Management Plans and Safety Data Exchange Agreements, were applicable.
? Oversees and participates in SAE reconciliation.
? Implements operational aspects of studies according to associated timelines, including: Global Safety Database set-up, production of safety reporting forms, SUSAR processes, and trial summaries created and maintained for case management team.
? Works cross-functionally with Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others during study set-up, maintenance, and closure.
? Investigates cases requiring Corrective and Preventative Action plans and ensures appropriate actions are taken.
? Initiates and assists with trial-related operational process changes and associated updates of controlled documents and timely communications.
? Acts as subject matter expert on PV study operations during audits/inspections.
? Supports maintenance of PV regulatory compliance for clinical studies.
? Provides case processing back up as needed.
? Occasional travel may be necessary.
Required Skills:
? 5
years in drug safety/pharmacovigilance in pharmaceutical industry setting or the equivalent.
? Experience with interacting with third parties (e.g., contract service providers) preferred.
? Knowledgeable in Pharmacovigilance and GCP legislation required.
? Direct experience in GXP compliant quality systems preferred.
Educational Requirements:
Minimum of Bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required.
Master's or Doctorate level degree in health care related profession preferred.
Please respond by submitting your resume in a Word Document.
(Please include the job title and id# in the subject line)
We will not respond to everyone personally - qualified candidates will be contacted for an interview.
Estimated Salary: $20 to $28 per hour based on qualifications.
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