Product Safety and Compliance Specialist

Job Title: Product Safety and Compliance Specialist

Department: Legal and Regulatory Affairs / Pharmacovigilance / Product Compliance

Role Category: Drug Safety & Regulatory Compliance

Industry Type: Pharmaceuticals / Biotechnology / API / Formulations / Clinical Research

Employment Type: Full Time, Permanent

Experience Range: 4 to 10 years

Salary Range (INR): ₹6,00,000 – ₹18,00,000 per annum (depending on level of specialization and regulatory exposure)

Education Qualification:

Mandatory: Bachelor's Degree in Pharmacy, Life Sciences, Chemistry, or related field

Preferred: Master's Degree in Regulatory Affairs / Pharmacovigilance / Pharmaceutical Law; Certifications in GVP, ICH Guidelines, or Product Safety Compliance

Manufacturing / Corporate Locations: Gurugram

Key Responsibilities:

Ensure compliance with national and international regulations related to pharmaceutical product safety and legal requirements

Collaborate with regulatory and legal teams to monitor product safety performance, assess risk, and implement corrective actions

Maintain and update safety data sheets (SDS/MSDS) and ensure compliance with GHS and relevant labeling laws

Support pharmacovigilance (PV) activities including adverse event reporting, signal detection, and benefit-risk evaluation

Coordinate with global safety teams and regulatory agencies (e.g., CDSCO, USFDA, EMA) to submit periodic safety update reports (PSURs) and risk management plans (RMPs)

Conduct audits and inspections related to product safety compliance

Interpret and apply Good Pharmacovigilance Practices (GVP), ICH guidelines, and WHO norms

Support product registration processes by providing safety-related documentation and legal declarations

Ensure compliance with local labeling, packaging, advertising laws, and consumer protection laws

Key Skills Required:

Strong understanding of pharmacovigilance systems, regulatory safety reporting, and GxP compliance

Knowledge of national and international drug laws and product safety regulations

Excellent analytical and documentation skills

Ability to interpret complex regulatory guidance and communicate effectively with cross-functional teams

Proficiency with pharmacovigilance databases (e.g., ARISg, Oracle Argus), SOP development, and safety analytics

Attention to detail and ability to manage compliance in a high-stakes environment