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Senior Pharmacovigilance Reporting Associate

0-2 years
Not Disclosed
10 Sept. 18, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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 Pharmacovigilance Reporting Associate
Location: India – Chennai, Trivandrum, Bangalore (Remote/Office with Flex)
Department: Pharmacovigilance
Reports To: Senior Manager / PV Lead
Employment Type: Full-Time
Job Requisition ID: JR133444

Educational Qualification:

  • Bachelor’s degree in Life Sciences, Pharmacy, or related field (Advanced degree preferred)


Job Purpose:

Ensure accurate and timely reporting of safety data for pharmaceutical products, supporting pharmacovigilance processes and regulatory compliance while collaborating with cross-functional teams.


Key Responsibilities:

Safety Data Reporting:

  • Prepare and submit adverse event reports and safety data in accordance with regulatory requirements and internal policies.

  • Review and analyze safety data with clinical and regulatory teams, identifying trends and potential safety signals.

  • Assist in preparing periodic safety update reports (PSURs), annual reports, and other regulatory documents.

  • Monitor timelines for safety report submissions and manage any delays or issues proactively.

Data Management & Quality:

  • Maintain and update pharmacovigilance databases, ensuring data integrity and quality through careful data entry and validation.

  • Provide training and support to junior team members on reporting procedures and PV regulations.

Compliance & Audits:

  • Engage in audits and inspections by regulatory authorities, ensuring readiness and adherence to pharmacovigilance reporting requirements.

  • Stay informed about changes in regulatory guidelines and industry standards to maintain compliance and best practices.


Required Skills & Competencies:

  • Extensive experience in pharmacovigilance or drug safety reporting.

  • Strong understanding of pharmacovigilance regulations and guidelines.

  • Proven ability to prepare and submit accurate adverse event reports timely.

  • Strong analytical skills to interpret safety data and identify trends.

  • Excellent communication and interpersonal skills for cross-functional collaboration.

  • Proficiency in pharmacovigilance databases, reporting tools, and Microsoft Office Suite.

  • Ability to manage multiple priorities in a fast-paced environment with attention to detail.

  • Commitment to confidentiality and proper handling of sensitive patient information.


Desirable Skills & Experience:

  • Advanced degree in Life Sciences, Pharmacy, or related field.

  • Experience with global pharmacovigilance regulations and reporting standards.


What ICON Offers:

  • Competitive salary and comprehensive benefits, including health insurance, retirement planning, and flexible leave policies.

  • Global Employee Assistance Programme (TELUS Health) offering 24/7 access to support.

  • Life assurance and flexible country-specific benefits (childcare vouchers, gym memberships, travel subsidies, etc.).

  • Inclusive, diverse, and accessible work environment fostering growth and high performance.