Alkem Laboratories is hiring a Drug Safety Associate in Mumbai for its Pharmacovigilance and Drug Safety operations. This opportunity is ideal for B.Pharm graduates and Life Sciences post-graduates with pharmacovigilance experience who want to build a career in drug safety, Individual Case Safety Report (ICSR) processing, and regulatory pharmacovigilance compliance.
The Drug Safety Associate role at Alkem Laboratories focuses on ICSR case intake, safety database management using Argus, regulatory reporting, and pharmacovigilance quality processes. Candidates with hands-on exposure to Argus Safety Database, adverse event reporting, and pharmacovigilance SOPs will find this role particularly relevant.
Pharmacovigilance professionals working in drug safety associate jobs, PV associate roles, or safety database operations can leverage this position to gain experience with global safety reporting and stakeholder collaboration in drug safety monitoring.
Job Details
Position: Drug Safety Associate
Company: Alkem Laboratories
Location: Mumbai, Maharashtra, India
Employment Type: Full-time
Experience: 1โ3 Years
Department: Pharmacovigilance / Drug Safety
Key Responsibilities โ Drug Safety Associate
The Drug Safety Associate will support pharmacovigilance and drug safety operations, including:
1๏ธโฃ ICSR Processing and Safety Case Management
- Logging Individual Case Safety Reports (ICSR) into the Argus Safety Database
- Downloading regulatory ICSRs from safety reporting systems
- Performing accurate ICSR data entry and case documentation in Argus
- Ensuring compliance with pharmacovigilance regulatory timelines
2๏ธโฃ Pharmacovigilance Collaboration
- Collaborate with internal and external stakeholders for accurate safety data reporting
- Support pharmacovigilance workflow coordination across teams
3๏ธโฃ PV Documentation and SOP Management
- Participate in pharmacovigilance SOP updates and documentation
- Assist in maintaining compliance with global PV regulations
4๏ธโฃ Quality Management and PV Training
- Support quality management system (QMS) activities
- Assist in training stakeholders on pharmacovigilance principles and safety reporting processes
Eligibility Criteria
Candidates applying for the Drug Safety Associate job at Alkem Laboratories must meet the following requirements:
Education
- B.Pharm (Bachelor of Pharmacy)
OR - Post-Graduate degree in Life Sciences
Experience
- 1โ3 years of pharmacovigilance experience
- Exposure to ICSR processing and safety database systems
Preferred Skills
- Knowledge of Argus Safety Database
- Understanding of pharmacovigilance guidelines and safety reporting
- Strong documentation and communication skills
- Ability to collaborate with cross-functional stakeholders
Key Skills for Pharmacovigilance Professionals
- Pharmacovigilance
- Drug Safety Operations
- Individual Case Safety Reports (ICSR)
- Argus Safety Database
- Adverse Event Reporting
- Regulatory Safety Reporting
- PV Compliance and SOP Management
Why Work at Alkem Laboratories?
Alkem Laboratories is one of Indiaโs leading pharmaceutical companies with a strong presence in drug development, regulatory compliance, and pharmacovigilance operations. Working as a Drug Safety Associate at Alkem provides exposure to:
- Global pharmacovigilance standards
- Safety database management systems
- Regulatory reporting workflows
- Quality management in drug safety
This role helps professionals build expertise in pharmacovigilance case processing, regulatory safety reporting, and global drug safety compliance.
Salary Expectations
Estimated salary for Drug Safety Associate in Mumbai Pharmacovigilance roles:
โน4.2 LPA โ โน7 LPA (depending on experience and PV skills)
How to Apply
