Job Title:
Senior Safety Specialist (Afternoon Shift)
Experience Required:
5+ years
Job Type:
Full-time
Location:
Remote, India
Department:
Clinical Research Services
Function:
Pharmacovigilance (PV) / Drug Safety
Work Schedule:
Second Shift (Afternoons)
Environment:
Office / Remote
Job Description
Functional Role:
Senior Safety Specialist (Pharmacovigilance)
Department:
Clinical Research Services (PPD® Portfolio)
Reporting To:
PV Project/Team Lead or Department Manager
Primary Responsibilities:
Perform and may oversee day-to-day pharmacovigilance (PV) activities such as case collection, monitoring, assessment, evaluation, and tracking of safety information.
Work independently with minimal supervision to manage case intake and ensure accuracy and regulatory compliance.
Provide leadership in the implementation of clinical safety processes, contribute to SOP development, and mentor junior staff.
Review safety data and peer-entered case reports for quality, consistency, and regulatory compliance.
Stay informed about regulatory changes, therapeutic developments, and safety management procedures.
Lead routine project activities including setup, coordination, and client communication for safety oversight (e.g., Clinical Trials, DSMB/EAC processes).
Support preparation for audits and inspections as needed.
Contribute to metrics review, forecasting, and budget-related planning for PV functions.
Participate in client and investigator meetings; provide subject-matter expertise.
Education & Experience:
Bachelor’s degree in life sciences, healthcare, pharmacy, or a related field.
Minimum 5 years of experience in pharmacovigilance or clinical safety in a CRO/pharmaceutical/biotech environment.
Knowledge, Skills & Abilities:
Strong understanding of pharmacovigilance processes and global regulatory safety requirements.
Solid knowledge of disease pathophysiology and therapeutic areas relevant to adverse event (AE) processing.
Strong critical thinking, analytical, and problem-solving skills.
Excellent written and verbal communication skills including medical paraphrasing.
Ability to work independently under minimal supervision and manage competing priorities and deadlines.
Experience with clinical study administration, including safety data metrics, budgeting, and forecasting.
Computer proficiency, including MS Office (Excel, Word, Outlook) and pharmacovigilance databases.
Capable of functioning in high-pressure environments with professionalism and a team-oriented mindset.
Benefits:
Competitive salary and annual performance bonus
Comprehensive healthcare package
Flexible remote work culture
Professional development and growth opportunities
Inclusion in a collaborative and innovative global team
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