Research Associate

1 day ago

Gurgaon, Haryana, India beBeePharmacovigilance Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title:
Research Associate - Pharmacovigilance Specialist

Job Summary:
Assist in the identification and management of adverse drug reactions, conducting systematic literature searches and ensuring compliance with regulatory requirements.

Responsibilities:
- Conduct comprehensive literature searches to identify safety-relevant information across multiple databases.
- Extract and summarize key safety data from identified sources, ensuring accuracy and regulatory compliance.
- Develop and validate search strategies for pharmacovigilance purposes, applying thorough knowledge of literature databases and regulatory requirements.
- Collaborate in the processing of Individual Case Safety Reports (ICSRs), evaluating data completeness, accuracy, and regulatory reportability.
- Assist in generating timely, consistent, and accurate reporting of expedited reports according to applicable regulations.
- Maintain safety tracking for assigned activities, performing literature screening and review as required.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File as appropriate.

Qualifications:
- Bachelor's degree in life science or equivalent combination of education and experience.
- Proficiency in Microsoft Office Suite and safety database systems, with a good understanding of clinical trial processes and pharmacovigilance principles.
- Strong communication and interpersonal skills, with ability to work independently and in a team environment.
- Excellent organizational skills, with proven ability to prioritize tasks and meet deadlines.

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