Drug Safety Associate

1-2 years

Not Disclosed

Bangalore Chennai

10 May 7, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Share your CV - recruitment.bangalore@navitaslifesciences.com

Position: Drug Safety Associate
Location: Bangalore/Chennai
Experience: 1-2 years

Summary:

Motivated and detail-oriented Drug Safety Associate with 1-2 years of experience in pharmacovigilance. Proficient in adverse event reporting, case processing, and regulatory compliance. Seeking to leverage expertise in drug safety to contribute to the safety monitoring and risk management of pharmaceutical products.

Key Responsibilities:

Processing adverse event reports in accordance with standard operating procedures (SOPs) and regulatory requirements.
Conducting initial assessment of adverse event cases to determine seriousness, causality, and expectedness.
Performing data entry, coding, and narrative writing for adverse event cases in safety databases.
Liaising with healthcare professionals and consumers to obtain additional information for case processing.
Participating in safety surveillance activities, including signal detection and trend analysis.
Contributing to the preparation of periodic safety reports (e.g., PSURs, DSURs) for regulatory submissions.
Assisting in the coordination of safety data exchange agreements with business partners and regulatory authorities.

Requirements:

Bachelor's degree in pharmacy, life sciences, nursing, or related field.
1-2 years of experience in pharmacovigilance or related field.
Knowledge of pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA).
Familiarity with adverse event reporting systems and safety databases (e.g., ARISg, Argus).
Strong attention to detail and accuracy in data entry and case processing.
Excellent communication skills and ability to work effectively in a team environment.
Proficiency in Microsoft Office Suite and electronic document management systems.

Preferred Qualifications:

Certification in pharmacovigilance (e.g., RAPS RAC, DIA PV Program).
Experience with medical coding systems (e.g., MedDRA, WHO Drug).
Understanding of medical terminology and pharmacology principles.
Ability to prioritize tasks and manage multiple deadlines effectively.

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Drug Safety Associate

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