Novotech has announced an opportunity for a Drug Safety Associate / Pharmacovigilance Associate for professionals with experience in pharmacovigilance, clinical trial safety and ICSR case processing.
This Novotech Drug Safety Associate job involves end-to-end safety activities including SAE, SUSAR and AE case processing, safety narrative writing, safety database documentation, regulatory safety submissions, literature surveillance, clinical study reconciliation and TMF documentation.
Candidates with a pharmacy, nursing, biomedical, health sciences or related scientific degree and approximately 2–4 years of pharmaceutical or CRO experience in drug safety are suitable for this opportunity.
The position is particularly relevant for pharmacovigilance professionals looking to strengthen their experience in clinical trial safety, regulatory reporting, safety database management and global drug safety operations.
About Novotech
Novotech is a global full-service Contract Research Organization (CRO) providing clinical research and scientific advisory services to biotechnology and pharmaceutical organizations.
Established in 1997, Novotech operates across Asia-Pacific, the United States and Europe and supports clinical development programs across multiple therapeutic areas.
Key Responsibilities
As a Drug Safety Associate at Novotech, selected candidates may be responsible for:
- Preparing project-specific Safety Management Plans (SMPs).
- Preparing safety database configuration documentation for clinical studies.
- Developing safety presentations and materials for project kick-off meetings.
- Performing ICSR case processing for adverse events, serious adverse events and SUSARs.
- Reviewing safety information and drafting accurate safety narratives.
- Monitoring project-specific drug safety mailboxes.
- Filing pharmacovigilance and clinical safety documentation within the Trial Master File (TMF).
- Managing applicable unblinding procedures for clinical studies.
- Conducting literature searches for potential adverse event and safety information.
- Monitoring applicable post-approval safety commitments.
- Participating in clinical study safety reconciliation activities.
- Coordinating with medical monitors, drug safety physicians, clients and clinical study teams to obtain missing safety information.
- Supporting pharmacovigilance inspections and audits.
- Assisting with Corrective and Preventive Actions (CAPA) associated with case-processing activities.
- Ensuring timely submission of safety reports to applicable regulatory authorities.
- Maintaining submission tracking information to demonstrate regulatory compliance.
- Providing on-the-job training and mentoring to junior team members.
Educational Qualifications
Candidates applying for the Novotech Pharmacovigilance Associate vacancy should have one of the following or another relevant scientific qualification:
- Pharmacy degree
- Registered Pharmacist qualification
- Registered Nursing qualification
- Biomedical Sciences degree
- Health Sciences degree
- Life Sciences or related scientific qualification
A postgraduate qualification or certification in clinical trials or clinical research will be considered an advantage.
Experience Required
Novotech specifies approximately 2–4 years of pharmaceutical or CRO experience, with a focus on safety-related activities in clinical trials.
Candidates with previous exposure to the following areas may have an advantage:
- Pharmacovigilance
- Drug Safety
- Clinical Trial Safety
- ICSR Processing
- SAE/SUSAR Processing
- Regulatory Safety Reporting
- Safety Database Operations
- Medical Coding
- Safety Narrative Writing
This is therefore primarily an experienced pharmacovigilance position rather than a fresher-level Drug Safety Associate vacancy.
Skills Required
Candidates should possess knowledge or practical experience in:
Pharmacovigilance & Clinical Safety
- ICSR case processing
- AE/SAE/SUSAR handling
- Clinical trial safety
- Safety narratives
- Safety mailbox monitoring
- Safety reconciliation
- Literature surveillance
Regulatory & Compliance
- ICH-GCP
- International drug safety reporting requirements
- Regulatory safety submissions
- Standard Operating Procedures (SOPs)
- Audit and inspection support
- CAPA processes
Technical & Medical Skills
- Medical terminology
- Medical coding terminology
- Safety databases
- Clinical trial documentation
- TMF documentation
- Summarization of medical information
Candidates should also demonstrate strong written and verbal English communication, interpersonal skills, time management and the ability to handle multiple priorities.
Estimated Salary
Estimated Salary Range: ₹5,00,000 – ₹9,00,000 per year
Important: Novotech has not disclosed an official salary range in the supplied job description. The figure above is an editorial market estimate for comparable pharmacovigilance positions in India and should not be interpreted as salary offered or guaranteed by Novotech.
Actual compensation can vary according to experience, location, technical expertise and company compensation policies.
Employee Benefits
According to the job description, Novotech provides an employee-focused working environment with benefits and programs that may include:
- Flexible working options
- Paid parental leave
- Flexible leave entitlements
- Wellness programs
- Professional development programs
- Mentorship opportunities
- Flexible benefits through the NovoLife framework
- Collaborative global working environment
- Career development opportunities within clinical research and biotechnology
Specific benefits may vary depending on employment location and applicable company policies.
Who Should Apply?
This opportunity may be suitable for professionals currently working as:
- Drug Safety Associate
- Pharmacovigilance Associate
- Patient Safety Associate
- Safety Associate
- Clinical Safety Associate
- ICSR Case Processor
- Pharmacovigilance Executive
- Drug Safety Executive
Candidates with 2–4 years of hands-on pharmacovigilance experience, particularly in clinical trial safety, ICSR processing and regulatory safety reporting, are likely to be the strongest match.
How to Apply
