Regulatory Review Advisor - Global Business Services Astrazeneca

3.0 - 5.0 years

3 - 6 Lacs

Bengaluru / Bangalore, Karnataka, India

On-site

Regulatory Reporting Compliance Ensure timely and accurate submission of regulatory reports, including Adverse Event Reports, Periodic Safety Update Reports, and other required documentation Interpret and apply global regulatory reporting requirements including those for health authorities Monitor updates to regulatory guidelines and ensure internal GBS processes align with evolving reporting standards Adverse Event and Safety Reporting Coordinate pharmacovigilance reporting activities, ensuring compliance with Good Pharmacovigilance Practices Work closely with safety teams to assess, process, and submit Individual Case Safety Reports within required timescales Assist in detection and risk assessment activities to client safety protocols Regulatory Documentation & Submissions Prepare, review, and submit regulatory reports, ensuring completeness, accuracy, and compliance within legal requirements Maintain documentation for regulatory audits and inspections Collaborate with cross-functional teams (e.g., Quality Assurance, Medical Affairs, Client PS Teams) to ensure alignment on regulatory reporting requirements Training and Process Improvement Provide training and guidance to GBS internal teams on regulatory reporting obligations and best practices Support audits and inspections by regulatory authorities and implement corrective actions as needed General Actively contribute to maintaining the core components of Good Pharmacovigilance Practice, via contribution to all safety-related processes and brand activities within countries of remit and being audit and inspection ready. Support external service providers to meet the company and local regulatory PV requirements. Complete all required patient safety trainings in adherence to internal processes and external regulations, and obtain access to relevant systems, such as Safety Database, Regulatory systems, Human Resources systems, Quality Management Systems, and other global or local systems commercial databases as appropriate. Maintain current and in-depth knowledge of: Relevant country regulatory authority regulations Global and local procedural and guidance documents Conditions, obligations, and other commitments relating to product safety or the safe use of AZ products Essential Skills/Experience: Bachelors degree in pharmacy, Life Sciences, Regulatory Affairs, or a related field 3 years + of experience in regulatory affairs, pharmacovigilance or regulatory reporting in the pharmaceutical industry Pharmacovigilance knowledge excellence Good Pharmacovigilance Practice Knowledge of health authority s regulations Cross-functional collaborative approach Effective and lateral thinking Problem-solving Vendor management Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Medical knowledge in company Therapeutic Areas Successful participation in above-market projects Audit & Inspection experience

Posted 1 month ago

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