Associate Pharmacovigilance Specialist

0-2 years

2-4 LPA

Bangalore

10 July 22, 2024

Job Description

Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Pharmacovigilance Specialist-8

Locations:

Available in 2 locations
Remote: Hybrid

Industry:

Life Sciences & Healthcare

Job Details:

Job ID: JREQ128380
Posted Date: July 19th, 2024

Job Description:

Pharmacovigilance professionals perform pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms, medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

Requirements:

Education: Master’s Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.)
Experience: At least 2 years of experience reviewing biomedical literature for adverse event reporting OR an equivalent combination of education and experience
Skills:
- Writing skills to support the creation of succinct, accurate, and precise summaries
- Working knowledge of biomedical terminology, drugs, and therapeutic areas

Responsibilities:

Critically analyze large numbers of articles from biomedical published literature and internal drug safety alerts.
Identify individual case safety reports (ICSRs) and other potential safety-relevant information impacting the risk-benefit and/or safety profile of customer’s products, as per regulatory requirements and standard operating procedures.
Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.
Demonstrate understanding of client’s drug labels and use that knowledge effectively when performing safety assessments.
Complete drug safety reviews of each biomedical literature batch in a timely, thorough, and accurate manner in accordance with client’s standards of timeliness and quality.
Use the drug safety system to track all actions and assessments in an audit-ready reference history.
Select articles specific to client’s interest for inclusion in the client's product literature database per guidelines.
Write accurate, detailed, and complete abstracts of selected articles using good judgment regarding the level of detail required and excellent organization, grammar, and syntax.
Extract key points of articles and create comprehensive and detailed indexes of the abstract contents to ensure precise and complete retrieval of literature from the client’s database.
Ensure timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines.
Maintain an awareness of new drugs and new therapeutic categories, new disease entities, and changes in biomedical terminology in the published literature.
Participate in other duties such as searches and terminology maintenance according to business needs and per the training provided.

About the Team:

The Pharmacovigilance team at Clarivate provides services to multiple global customers covering all therapeutic areas. It offers a supportive working environment with personalized training and opportunities to engage in different aspects of pharmacovigilance and customer engagement.

Hours of Work:

Based out of India (Bangalore or Noida)
Monday-Friday
Hybrid work mode

Equal Employment Opportunity:

At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.