Manager - Pharmacovigilance

Linux Laboratories; Chennai District; On-site; INR 500,000 - 750,000; Full time

Job summary

Linux Laboratories in Chennai is seeking a Pharmacovigilance professional to manage adverse event reporting, case investigations, and regulatory submissions.

The role requires 2–5 years in PV, strong data integrity, and knowledge of GCP. You will collaborate with medical teams to ensure patient safety and timely safety documentation.

Qualifications

• Bachelor's degree in Pharmacy (B.Pharm) or M.Pharm in Pharmacology.
• PV certification from recognized institution.
• Valid State Pharmacy Council registration (if applicable).

Responsibilities

• Receive and document ADRs from HCPs, consumers, and field staff.
• Conduct case investigations using standard forms and criteria.
• Evaluate causality, severity, and outcome of events.
• Prepare SAE reports for DCGI and ethics committees.
• Maintain PSUR and DSUR, plus safety summaries.
• Ensure data integrity and GCP compliance in PV databases.
• Coordinate with clinical teams on safety inquiries.
• Attend regulatory meetings and present safety data.

Skills

Pharmacovigilance

Adverse event reporting

GCP compliance

Regulatory submissions

Data integrity

Communication skills

Education

B.Pharm

M.Pharm in Pharmacology

PV Certification

Tools

PV databases

Regulatory submission software

ICH guidelines databases

Job description

Role & responsibilities

• Receive, record, and document adverse drug reactions (ADRs) from healthcare professionals, consumers, and field staff.
• Conduct thorough investigation of reported ADRs using standard case investigation forms and assessment criteria.
• Evaluate causality, severity, and outcome of reported adverse events using standardized pharmacovigilance tools.
• Prepare and submit Serious Adverse Event (SAE) reports to DCGI and IEC/ethics committee within stipulated timelines.
• Maintain periodic safety update reports (PSUR), including preparation of development safety update reports (DSUR) as required.
• Generate Periodic Safety Update Report (PSUR) and development safety update reports (DSUR).
• Prepare safety summaries and risk assessments for regulatory submissions and clinical trial documentation.
• Maintain accurate pharmacovigilance databases and ensure proper data integrity and GCP compliance.
• Perform signal detection and trend analysis of adverse events using statistical and observational methods.
• Conduct literature review and competitor intelligence on product safety profiles
• Prepare and maintain Standard Operating Procedures (SOPs) for pharmacovigilance processes
• Coordinate with clinical teams, medical representatives, and other CFTs on safety-related inquiries
• Maintain traceability for all pharmacovigilance activities for inspection readiness.
• Attend regulatory meetings and provide safety data presentations as required

REQUIRED QUALIFICATIONS

• Bachelor's degree in Pharmacy (B.Pharm), or Post-graduate qualification (M.Pharm) in Pharmacology preferred.
• Certification in Pharmacovigilance (e.g., Diploma in Pharmacovigilance from recognized institutions).
• Valid pharmacy registration with respective State Pharmacy Council (if applicable)

EXPERIENCE REQUIREMENTS

• 2-5 years of professional experience in pharmacovigilance, medical safety, or drug safety monitoring in pharmaceutical industry or clinical research
• Demonstrated experience with adverse event reporting systems and pharmacovigilance software/databases
• Experience in preparing regulatory submissions and safety documentation for DCGI/FDA
• Exposure to clinical trial safety monitoring and GCP compliance
• Experience with international pharmacovigilance guidelines (ICH E2A, ICH E2C, WHO guidelines) is beneficial

Preferred candidate profile

CORE COMPETENCIES & KNOWLEDGE

• Strong attention to detail and accuracy in documentation
• Excellent written and verbal communication skills in English and regional languages
• Problem-solving and analytical thinking abilities
• Team collaboration and cross-functional coordination
• Commitment to regulatory compliance and patient safety