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Sr Safety Specialist (Afternoon 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 (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