Associate Safety Specialist

This is a fully remote position, open to applicants in India.

📋 Description

• Execute daily Pharmacovigilance tasks within a highly regulated setting.

• Engage in on-call responsibilities for designated projects to provide 24-hour case-intake support.

• Gather, oversee, evaluate, research, and monitor safety data.

• Input, classify, and analyze adverse-event information.

• Evaluate cases and carry out follow-up procedures.

• Monitor reports and execute regulatory reporting functions.

• Review pharmacovigilance literature and information sources to remain updated on regulations, practices, procedures, and proposals.

• Retain a medical comprehension of relevant therapeutic areas and disease conditions.

• Assess cases for quality, consistency, and precision, including peer reviews.

• Prepare and uphold regulatory safety documentation.

• Collaborate with project team members, client representatives, investigators, adverse-event reporters, and external vendors.

⛳️ Requirements

• Bachelor's degree or equivalent relevant academic/vocational qualification.

• Prior experience ranging from 0 to 2 years is preferred.

• Consideration may be given to a combination of suitable education, training, and/or directly related experience.

• Strong analytical and problem-solving abilities.

• Proficient oral and written communication skills, including the ability to paraphrase effectively.

• Good command of English and the capability to translate information into the local language when necessary.

• Proficient in computer skills and adept at working across multiple databases.

• Familiarity with Microsoft Office applications, including Outlook, Word, and Excel.

• Knowledge of medical terminology.

• Understanding of procedural documents and regulatory guidelines.

• Ability to manage and prioritize diverse tasks while meeting tight deadlines with minimal supervision.

• Exceptional attention to detail.

• Capacity to maintain a positive and professional attitude in challenging situations.

• Ability to collaborate effectively within a team setting.

• Willingness to occasionally work extended and varied hours.

• Willingness to travel occasionally, both domestically and internationally.

🏝️ Benefits

• Global team atmosphere.

• Opportunities for collaboration and professional development.

• A workplace focused on scientific excellence.