Job Title:
Senior Safety Specialist (Night Shift)
Experience Required:
5+ years
Job Type:
Full-time
Location:
Remote, India
Department:
Clinical Research Services
Function:
Pharmacovigilance (PV) / Drug Safety
Work Schedule:
Third Shift (Night Shift: 5:30 PM to 2:30 AM IST, Mon–Fri)
Environment:
Office / Remote
Job Description
Functional Role:
Senior Pharmacovigilance Specialist
Department:
PPD® Clinical Research – Drug Safety Services
Reporting To:
PV Team/Project Lead
Primary Responsibilities:
Independently perform day-to-day pharmacovigilance activities, including case collection, monitoring, evaluation, and data tracking.
Act as a lead on designated projects; provide mentorship and support to junior staff.
Review peer case entries for quality, completeness, accuracy, and regulatory compliance.
Participate in project implementation and coordination of safety processes (e.g., DSMB, EAC, Clinical Trials).
Provide input into SOPs and departmental procedures, and prepare for audits or inspections.
Engage in medical literature review and stay current on global safety regulations and pharmacovigilance trends.
Handle on-call duties when necessary to ensure 24-hour case intake.
Education & Experience:
Bachelor's or Master’s degree in Life Sciences or Clinical Sciences.
Minimum 5 years of hands-on experience in case processing using Argus Safety Database.
Prior experience working with Post-Marketing Surveillance (PMS) and Clinical Trial (CT) cases is essential.
Must be available for immediate joining.
Willingness to work night shifts (IST 5:30 PM to 2:30 AM).
Knowledge, Skills & Abilities:
Strong understanding of global pharmacovigilance regulatory requirements and GVP/GCP guidelines.
In-depth knowledge of therapeutic areas, adverse event assessment, and pathophysiology.
Excellent problem-solving, decision-making, and critical thinking skills.
Proficiency in case narratives, coding, and compliance documentation.
Exceptional verbal and written communication; ability to paraphrase and summarize accurately.
Familiarity with multiple safety databases; strong computer literacy.
High attention to detail, and ability to work effectively under pressure and deadlines.
Team-oriented with a positive, professional demeanor.
Benefits:
Competitive compensation and shift allowances.
Career growth with a global industry leader.
Supportive, inclusive, and innovative remote work culture.
Comprehensive health and wellness programs.
Opportunities to work on global clinical research initiatives that make a real impact.
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