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Clinical Safety Associate- Vaf 161

0-2 years
Not Disclosed
10 March 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Clinical Safety Associate - VAF 161
Location: India (Remote Work Possible)
Department: Safety and Vigilance
Contract Type: Permanent

Job Description:
ProductLife Group is looking for a Clinical Safety Associate to join our dynamic team and contribute to the activities performed in the Hub.

Responsibilities:

  • Processing of Adverse Events (AEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs), along with other immediately reportable events in the safety database, including relevant communication with the Customer.

  • Preparation, sending, and follow-up of queries.

  • Maintenance of study trackers and other relevant tools.

  • Reconciliation of clinical safety information/activities with Customer/CRO/Data Management.

  • Assisting in the preparation of aggregate periodic safety reports.

  • Assisting in the submission of expedited and periodic safety reports.

Education and Experience:

  • BSc or equivalent in Life Science discipline or PharmD.

  • Experience in Pharmacovigilance/Drug Safety Data Entry.

  • Knowledge of databases (Safety database: SafetyEasy).

  • Understanding of drugs and the pharmaceutical environment.

  • Familiarity with Pharmacovigilance/Drug Safety regulations (national and international) and Pharmacovigilance tools.

  • Demonstrable case management experience.

Skills:

  • Adaptability.

  • Analytical skills.

  • Flexibility.

  • Reliability.

  • Good writing skills.

  • Proficiency in using MS Office tools and Pharmacovigilance tools.