Pharmacovigilance Associate - Drug Safety Operations

Why This Role Matters
The Pharmacovigilance Associate plays a critical role in ensuring patient safety by monitoring and evaluating adverse drug reactions and other safety information. The role contributes to maintaining drug safety standards and regulatory compliance while supporting global pharmacovigilance operations within clinical research and pharmaceutical environments.

Job Description
The Pharmacovigilance Associate will support drug safety monitoring activities including collection, processing, and evaluation of adverse drug reaction reports. The role involves working with safety databases, preparing regulatory safety documentation, and collaborating with clinical and regulatory teams to ensure compliance with global pharmacovigilance guidelines.

Key Features of the Role
• Opportunity to work in pharmacovigilance and drug safety operations
• Exposure to global PV regulations including ICH, EMA, FDA, and CDSCO
• Involvement in safety case processing and regulatory reporting
• Collaboration with clinical research, regulatory affairs, and quality teams
• Professional development in clinical research and pharmacovigilance
• Candidate must agree to a 2-year employment agreement
• Rotational shifts (mandatory)

Responsibilities
• Collect and process Individual Case Safety Reports (ICSRs) from healthcare professionals, patients, and literature sources
• Perform data entry and medical coding of adverse events using safety databases such as Argus or ARISg
• Conduct case assessment, narrative writing, and quality review of safety reports
• Support preparation of aggregate safety reports including PBRERs, PSURs, and DSURs
• Assist in signal detection, risk assessment, and benefit–risk evaluation activities
• Ensure compliance with global pharmacovigilance regulations and guidelines
• Collaborate with cross-functional teams including clinical operations, regulatory affairs, and quality assurance
• Participate in audits, inspections, and implementation of corrective and preventive actions (CAPA)
• Maintain updated knowledge of pharmacovigilance guidelines and regulatory requirements

Required Qualifications

Educational Requirements:
• Doctor of Pharmacy (Pharm.D) – Mandatory

Experience and Skills:
• 0–5 years of experience in pharmacovigilance or drug safety operations
• Knowledge of pharmacology, drug safety, and clinical research practices
• Understanding of pharmacovigilance guidelines including ICH E2A–E2E and GVP modules
• Experience with safety databases such as Argus or ARISg preferred
• Strong analytical and documentation skills
• Excellent written and verbal communication abilities
• Proficiency in Microsoft Office tools

Salary Insights:
• Salary offered as per company norms

Company Overview
Forward Life Pvt. Ltd. is a growing Clinical Research Organization providing services in clinical operations, pharmacovigilance, regulatory affairs, and quality management. The company operates with global standards and supports pharmaceutical and healthcare organizations in clinical research and regulatory compliance activities.

FAQs
• What qualification is required for this role?
Candidates must have a Doctor of Pharmacy (Pharm.D) degree.

• How much experience is required?
Candidates with 0–5 years of experience in pharmacovigilance or related fields can apply.

• Where is the job located?
The role is based in Hyderabad, Telangana, India.

• What shift schedule is required?
Candidates must be willing to work in rotational shifts and agree to a 2-year employment agreement.

Application Tips
• Highlight pharmacovigilance internships or experience in drug safety
• Mention knowledge of ICSR processing and safety database systems
• Include familiarity with global PV guidelines such as ICH and GVP
• Showcase analytical and medical writing skills related to safety reporting
• Emphasize teamwork and ability to work in regulatory and clinical environments