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Post : Pharmacovigilance Analyst
Job Description:
Job Purpose:
The Pharmacovigilance (PV) Analyst is responsible for adverse event reporting activities including data entry, quality control (QC), follow-up, medical review, and documentation. Responsible for and supports various PV activities. This will involve liaising with global pharmacovigilance colleagues to ensure that the events have been entered correctly and submitted successfully to regulatory authorities within regulatory compliant timelines. The PV Analyst will also be required to collaborate on SOP preparation, review, and updates.
Job Purpose:
The Pharmacovigilance (PV) Analyst is responsible for adverse event reporting activities including data entry, quality control (QC), follow-up, medical review, and documentation. Responsible for and supports various PV activities. This will involve liaising with global pharmacovigilance colleagues to ensure that the events have been entered correctly and submitted successfully to regulatory authorities within regulatory compliant timelines. The PV Analyst will also be required to collaborate on SOP preparation, review, and updates.
Job Responsibilities:
• Contribute to the management of safety cases, including case intake/triage, data entry, quality review, medical review, and follow up activities
• Case management of reports from all sources
• Prepare case narratives and assign or evaluate appropriateness of MedDRA coding including follow-up updates
• Maintain a working knowledge of the safety database
• Support for SOP review, update, development
• Support for global document preparation and review (i.e., PBRERs)
• Conduct and assess literature searches
• Participate in global safety meetings (i.e., GET, GSC)
• Training (New hires, annual refresher, vendors)
• Support for regulatory submission preparation and review
• Support for Medical Information Inquiries
• Support for audit activities related to pharmacovigilance
• Reconciliation and Records Retention
• Maintain working knowledge of regulatory rules and regulations, including monitoring for new or changing regulation
• Acts as a back-up for Kowa global safety database local administrator
• Performs other duties as assigned
• Contribute to the management of safety cases, including case intake/triage, data entry, quality review, medical review, and follow up activities
• Case management of reports from all sources
• Prepare case narratives and assign or evaluate appropriateness of MedDRA coding including follow-up updates
• Maintain a working knowledge of the safety database
• Support for SOP review, update, development
• Support for global document preparation and review (i.e., PBRERs)
• Conduct and assess literature searches
• Participate in global safety meetings (i.e., GET, GSC)
• Training (New hires, annual refresher, vendors)
• Support for regulatory submission preparation and review
• Support for Medical Information Inquiries
• Support for audit activities related to pharmacovigilance
• Reconciliation and Records Retention
• Maintain working knowledge of regulatory rules and regulations, including monitoring for new or changing regulation
• Acts as a back-up for Kowa global safety database local administrator
• Performs other duties as assigned
Candidate Profile
• Required: Pharmacy Degree (Pharm.D. or R.Ph. with relevant clinical experience)
• Proficient in MS Office and Adobe Acrobat
• Prior work experience in Life Sciences preferred
• Experience with ARGUS preferred
• Must display significant analytical and clinical skills
• Requires excellent narrative writing skills
• Travel (including international travel from time to time) to visit partners and attend relevant conferences or meetings may be required. Candidate must be willing to travel up to 20% of the time. Flexibility in scheduling travel also required.
• Required: Pharmacy Degree (Pharm.D. or R.Ph. with relevant clinical experience)
• Proficient in MS Office and Adobe Acrobat
• Prior work experience in Life Sciences preferred
• Experience with ARGUS preferred
• Must display significant analytical and clinical skills
• Requires excellent narrative writing skills
• Travel (including international travel from time to time) to visit partners and attend relevant conferences or meetings may be required. Candidate must be willing to travel up to 20% of the time. Flexibility in scheduling travel also required.
Additional Information:
Industry Type : Pharma
SALARY AROUND: 100000 usd / YEAR
Qualification : Pharm.D. or R.Ph.
Location : Corporate, Montgomery, AL, US
Last Date : 30th October, 2018
Industry Type : Pharma
SALARY AROUND: 100000 usd / YEAR
Qualification : Pharm.D. or R.Ph.
Location : Corporate, Montgomery, AL, US
Last Date : 30th October, 2018
