Drug Safety Specialist

Selva Infosys LLC

About the Role

Full-time, on-site position based in Ahmedabad.

The Drug Safety Specialist monitors, evaluates, and documents medication safety data, including adverse events and product complaints, in alignment with internal procedures and regulatory standards.

Key Responsibilities

• Reviewing clinical and real-world safety information.
• Performing risk assessments.
• Preparing safety reports.
• Supporting signal detection activities.
• Collaborating with regulatory affairs, clinical, pharmacy, and medical teams to ensure accurate reporting, compliance with local and international regulations, and timely communication of safety findings.
• Contributing to the development and maintenance of standard operating procedures.
• Supporting internal audits and quality improvement initiatives.

Requirements & Tech Stack

• Regulatory Requirements
• Regulatory Affairs (relevant to drug safety and pharmacovigilance)
• Pharmacy or Medicine background
• Clinical Trials (experience working with or supporting)
• Safety data collection, documentation, and reporting
• Medical terminology
• Safety case processing
• Preparation of safety summaries or reports
• Pharmacovigilance systems (familiarity is an advantage)
• Safety databases (familiarity is an advantage)
• Applicable global guidelines (e.g., ICH, FDA, EMA) (familiarity is an advantage)

Qualifications

• Ability to interpret prescribing information, safety profiles, and clinical data.
• Bachelor’s or master’s degree in Pharmacy, Medicine, Life Sciences, or a related discipline.
• Attention to detail.
• Strong analytical skills.
• Ability to manage multiple cases and deadlines simultaneously.
• Effective written and verbal communication skills.
• Ability to collaborate with cross-functional teams.