Instagram
youtube
Facebook

Sr Safety Specialist (Night Shift)

5+ years
Not Disclosed
10 June 2, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.