Senior Drug Safety Associate (QC) - Pharmacovigilance
by Synowledge PV Services India Pvt Ltd in Mysore
Experience: 1 to 2 yrs. | Salary: INR 3,25,000 - 3,75,000 P.A Posted on: 11 Sep
Job Description
YEARS OF EXPERIENCE: Minimum 1-2 years of experience in Pharmacovigilance
EDUCATION: Only HCP (Health Care Professionals)- B. Pharm, M. Pharm, B.Sc (Nursing), Pharm D, BPT, MPT, BDS, BAMS, BHMS. (Biochemistry and Microbiology will not be considered)
ESSENTIAL DUTIES AND RESPONSIBILITIES:
As Quality Check Reviewer
COMMUNICATION SKILLS:
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross department communication. Ability to document and communicate problem/resolution and information/ action plans.
DESIRED TECHNICAL SKILLS:
OTHER SKILLS:
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.
EDUCATION: Only HCP (Health Care Professionals)- B. Pharm, M. Pharm, B.Sc (Nursing), Pharm D, BPT, MPT, BDS, BAMS, BHMS. (Biochemistry and Microbiology will not be considered)
ESSENTIAL DUTIES AND RESPONSIBILITIES:
As Quality Check Reviewer
- Review data entered in safety database for completeness and accuracy.
- Provide quality feedback to team resources
- Track and maintain quality metrics
- Responsible for data entry of Individual case safety reports into the safety database.
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
- Process all incoming cases in order to meet timelines.
- Full data entry including medical coding and safety narrative.
- Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD).
- Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
- Following up with sites regarding outstanding queries.
- Follow up on reconciliation of discrepancies.
- Follow departmental AE workflow procedures.
- Closure and deletion of cases.
- Mentor and guide the activities of the Dug Safety Associate.
- High level of proficiency al all workflow tasks.
- Perform any other drug safety related activities as assigned.
- Basic competence with medical and therapeutic terminology.
- Ability to work independently but guided by documented procedures, with appropriate support.
- Able to work effectively as part of a team.
- Understanding of patient safety regulatory obligations.
- Should be familiar with regulatory & pharmacovigilance guidelines.
- Should be familiar with pharmacovigilance terminology.
- Excellent attention to detail.
- Ability to deliver within established timelines.
- Fluency in English and excellent comprehension.
- Computer literate.
- Relevant product and industry knowledge.
- Experience with relevant software applications.
COMMUNICATION SKILLS:
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross department communication. Ability to document and communicate problem/resolution and information/ action plans.
DESIRED TECHNICAL SKILLS:
- Person should be familiar with MS Office Tools.
- Safety database knowledge.
OTHER SKILLS:
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.
Education:
Salary: INR 3,25,000 - 3,75,000 P.A
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Production/Manufacturing/Maintenance
Role: Quality Assurance/Quality Control Manager
Keyskills: PharmacovigilanceDrug SafetyQuality Reviewnarrativeswriting narratives
Desired Candidate Profile
Education:
Please refer to the Job description above UG - B.Pharma - Pharmacy, MBBS - Medicine, B.Sc - Any Specialization, Nursing
PG - M.Pharma - Pharmacy, M.S/M.D - Any Specialization, M.Sc - Any Specialization, Nursing, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
PG - M.Pharma - Pharmacy, M.S/M.D - Any Specialization, M.Sc - Any Specialization, Nursing, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Company Profile
Synowledge PV Services India Pvt Ltd
Synowledge is a Global Management Consulting, Technology Services and Outsourcing Company focused in the Life Sciences & Healthcare Industry. With an annual growth rate of 300% and serving clients across 6 global offices (US, EU and Asia Pacific), Synowledge has gained market share to become the leading service provider in its space. Combining unparalleled experience and specialized capabilities within the Life Sciences industry, Synowledge has become a strategic partner with many Top 20 Pharma and Fortune 500 companies. Synowledge's technology solutions and innovative consulting services help life sciences companies reduce cost, accelerate growth and minimize time to market during the drug development lifecycle. 
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