Junior Pharmacovigilance Specialist

TransPerfect

1 years

0 Lacs

Pune Maharashtra India

Posted:1 day ago| Platform:

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Skills Required

pharmacovigilance analyze report support research analysis processing reports data integrity audit compliance documentation communication reporting risk drive coding gcp word powerpoint excel healthcare collaborative development

Work Mode

On-site

Job Type

Full Time

Job Description

OVERVIEW: The Junior Pharmacovigilance Specialist collaborates with the PV Solutions production team to analyze and report on safety parameters, within the context of patient safety against our clients’ products, and in line with client requirements for case review. DESCRIPTION: Perform various tasks in support of our clients’ clinical research including adverse event analysis and processing Prepare safety reports for submission to various health authorities Maintain data integrity and promote audit compliance by following Good Documentation Practice (GDP) standards Adhere to project timelines, with proactive communication with Team Lead and Project Managers, as needed Understand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and Standard Operating Procedures (SOPs) Analyze stakeholder complaints related to safety reporting, address in real time, and discuss with Project Managers to mitigate risk and implement/drive solutions Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor REQUIRED SKILLS: Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding Knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and International Conference on Harmonization (ICH) guidelines Proficiency in Word, PowerPoint, Excel, Outlook, EndNote, and scientific databases including PubMed, Embase, etc. Excellent written and oral communication skills in English Strong attention to detail and adherence to SOPs and client specifications REQUIRED EXPERIENCE AND QUALIFICATIONS: Minimum Bachelor's degree in pharmacy or Master degree in Life Science Experience (Preferred but Not Mandatory) 1+ year in Pharmacovigilance (for experienced candidates). Medical or healthcare-related experience is a plus Recent graduates with a strong academic background and interest in drug safety/pharmacovigilance are encouraged to apply Ability to work in collaborative, cross-functional teams (internships/academic projects may be considered) DESIRED SKILLS AND EXPERIENCE: Drug development/clinical trial knowledge Creative thinker – Curious and unafraid to ask questions Hard worker – Industrious and diligent in everything you do Innovator – Willing to initiate changes and introduce new ideas Team player who collaborates effectively Show more Show less