Drug Safety Specialist (Night Shift)

We are seeking a detail-oriented and motivated Drug Safety Specialist to support pharmacovigilance (PV) activities in a highly regulated environment. This role involves monitoring, evaluating, and reporting safety data to ensure compliance with regulatory standards and patient safety.

With a strong global presence, the organization has supported leading pharmaceutical companies and biotechnology firms across multiple clinical trials worldwide.

Key Responsibilities
Perform day-to-day pharmacovigilance (PV) activities, including case intake, data entry, coding, and adverse event (AE) assessment
Review, evaluate, and track safety information in compliance with regulatory requirements
Conduct case processing, follow-ups, and quality checks to ensure accuracy and consistency
Prepare and maintain regulatory safety reports
Collaborate with internal teams, clients, investigators, and third-party vendors
Support project implementation activities, including clinical trials and safety committees
Participate in audits, investigator meetings, and project kick-offs
Stay updated on pharmacovigilance regulations, guidelines, and therapeutic areas
Mentor junior team members where applicable
Education & Experience
Bachelor’s degree or equivalent qualification in a relevant field
Minimum 2+ years of experience in pharmacovigilance or related domain
Equivalent combinations of education, training, and experience may be considered
Required Skills & Competencies
Strong understanding of pharmacovigilance processes and adverse event reporting
Knowledge of clinical trials and regulatory requirements
Good understanding of disease processes and therapeutic areas
Strong analytical, critical thinking, and problem-solving skills
Excellent written and verbal communication skills
Proficiency in Microsoft Office (Word, Excel, Outlook)
Ability to work with multiple databases and systems
Strong attention to detail and ability to meet strict deadlines
Ability to work independently and collaboratively within a team
Work Environment
Office-based role with exposure to standard office equipment
Fast-paced environment requiring high concentration and accuracy
Regular interaction with internal teams and external stakeholders
Occasional extended working hours and travel (domestic/international)
Preferred Skills
Experience in Clinical Trials, Pharmacovigilance, and Project Implementation
Exposure to safety reporting, publication processes, and regulatory compliance