Medical Advisor Job at AstraZeneca Kolkata | Top Pharma Job Opportunity 2026
Looking for a Pharmacovigilance job to launch your career in drug safety? This Pharma Freshers job as a Safety Science Coordinator I is a great opportunity to gain hands-on experience in adverse event processing, safety reporting, and regulatory compliance. Fresh graduates aiming for a Pharmacovigilance job or a Pharma Freshers job can build a strong foundation in clinical safety through this role in Pune.
- Job Title: Safety Science Coordinator I
- Location: Pune
- Job Requisition ID: 26928
About the Company
Fortrea is a global contract research organization (CRO) that provides clinical development and patient access solutions to pharmaceutical, biotechnology, and medical device companies. The company focuses on delivering high-quality clinical trials and safety services while ensuring compliance with global regulatory standards.
Job Description
- Assist in overall Clinical Safety and PSS operations
- Handle the complete adverse events process (clinical trials & post-marketing)
- Manage and process expedited adverse events as per required standards
- Submit safety reports to clients and regulatory authorities within timelines
- Support client project groups or work as a standalone service provider
- Ensure high-quality, safe, and cost-effective service delivery
- Comply with Health and Safety regulations and company policies
Key responsibilities
- Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)
- Maintain adverse event tracking systems and documentation files
- Report safety data to clients, regulatory authorities, and stakeholders
- Log and manage AE/SAE reports accurately
- Perform data entry and write patient narratives using MedDRA
- Assist in the listness assessment and query generation
- Submit SAE reports within defined timelines
- Support quality review and database reconciliation
- Maintain compliance-related safety documentation
- Work under Quality Management Systems (SOPs, WIs)
- Coordinate archiving of safety study files
- Schedule meetings and support team coordination
- Train and mentor team members
- Ensure regulatory compliance and provide administrative support
Qualifications
- PharmD with 0-6 months of Safety experience or relevant experience
- A degree is preferred in a pharmacy-related area
- Speaking: English and the local language
- Writing/Reading: English and local language
Experience
- Good Team player and offers peer support as needed
- Ability to set priorities and handle multiple tasks
- Attention to detail
- Good written and verbal communication skills
- Logical and spelling skills
- Good keyboard skills with knowledge of MS Office and Windows
- Ability to operate standard office equipment
