Navitas Life Sciences is hiring for multiple positions across its Regulatory Affairs, Clinical Research, Pharmacovigilance and Drug Safety teams in Chennai and Bangalore, India.
The openings include opportunities in regulatory publishing and submissions, clinical data management, clinical data analysis, individual case safety report processing, aggregate safety reporting, signal management and pharmacovigilance quality assurance.
Candidates with qualifications in Pharmacy, Life Sciences, Medicine, Dentistry, Engineering and related disciplines can explore the available positions based on their experience and technical skills.
Job Details
| Particulars | Details |
|---|---|
| Company | Navitas Life Sciences |
| Job Locations | Chennai and Bangalore |
| Employment Type | Full-Time |
| Recruitment | Multiple Positions |
| Job Categories | Regulatory Affairs, Clinical Research, Pharmacovigilance |
| Application Email | recruitment.india@navitaslifesciences.com |
Available Positions at Navitas Life Sciences
1. Junior Regulatory Associate
Location: Chennai, India
Qualification: Bachelor’s Degree in Pharmacy
Experience Level: Junior
Category: Regulatory Affairs
Key Responsibilities:
- Understand regulatory submission requirements for IND, ANDA, NDA and DMF in CTD/eCTD formats.
- Support document-level publishing, including bookmarking, hypertext linking and preparation of Tables of Contents.
- Assist with submission publishing, archiving and review of same-day dispatches and complex submissions.
- Follow customer SOPs, policies and organizational procedures.
Required Skills:
- Experience in Regulatory Publishing and Submissions.
- Understanding of regulatory submission formats and agency requirements, including US-FDA, EMA and Health Canada.
2. Clinical Data Analyst
Location: Chennai and Bangalore, India
Qualification: Life Sciences or Engineering Graduate
Experience: 2.5–3 Years
Experience Level: Junior
Category: Clinical Research
Key Responsibilities:
- Create efficacy and safety tables, listings, figures, derived data specifications and datasets.
- Develop and validate SAS macros and utilities.
- Manage multiple projects and ensure timely delivery.
- Lead a team and work independently from Statistical Analysis Plans (SAPs) with minimal guidance from the Biostatistician.
Required Skills:
- SAS skills or certification.
- In-depth understanding of clinical development processes.
- Knowledge of real-world medicine and clinical data quality requirements.
3. Senior Drug Safety Associate
Location: Bangalore, India
Qualification: Graduate or Postgraduate Degree in Life Sciences, Pharmacy, Dentistry, Allied Health Sciences or related courses
Experience Level: Entry Level
Category: Pharmacovigilance and Safety
Key Responsibilities:
- Process Individual Case Safety Reports (ICSRs) in accordance with project requirements and applicable regulations.
- Enter and review case information in safety databases.
- Evaluate adverse event information and ensure accurate case processing.
- Meet project SLAs, quality standards and productivity targets.
- Perform data quality checks and generate follow-up queries.
- Resolve findings identified by Quality and Medical Reviewers.
- Ensure compliance with global pharmacovigilance regulations and SOPs.
- Support source document preparation, reconciliation and archival.
- Provide subject matter expertise, mentoring and training to team members.
Required Skills:
- Good written and spoken English.
- Knowledge of medical terminology.
- Understanding of GCP, pharmacovigilance principles and related regulations.
- Knowledge of MS Office.
- Understanding of patient safety.
4. QA Auditor – PV
Location: Bangalore, India
Qualification: Life Sciences Degree or Above; preference for MSc, M.Pharm, B.Pharm or BDS
Experience: 5+ Years in Global PV System Management
Category: Regulatory and Safety
Key Responsibilities:
- Implement and maintain pharmacovigilance systems, quality processes and metrics.
- Conduct audits of projects, systems, processes and vendors.
- Support preparations for customer audits and pharmacovigilance inspections.
Required Skills:
- 5+ years of experience in Global PV System Management.
- 3+ years of experience conducting GCP and GVP audits.
- Experience in CAPA Management.
- Strong understanding of GVP guidelines.
- 3+ years of experience managing PV Quality Management Systems.
5. Safety Specialist II
Location: Bangalore, India
Qualification: Graduate or Postgraduate Degree in Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences or related courses
Experience Level: Analyst
Category: Regulatory Affairs
Key Responsibilities:
Aggregate Safety Reports
- Author and review DSURs, PBRERs, PSURs, PADERs and Canadian Aggregate Reports.
- Review aggregate safety data and generate line listings and summary tabulations.
- Analyze safety and regulatory data to prepare aggregate reports.
- Conduct literature screening for relevant safety articles.
- Compile benefit-risk evaluation sections.
- Address internal and external reviewer comments.
- Participate in audits and inspections.
Signal Management and Risk Management Plans
- Conduct signal screening, data mining and frequency tabulation.
- Generate line listings and summary tabulations using Argus or client safety databases.
- Draft signal detection, validation, assessment and benefit-risk analysis.
- Track potential, open, refuted and validated signals.
- Develop Risk Management Plans in accordance with applicable SOPs.
Required Skills:
- Experience authoring and reviewing Aggregate Safety Reports.
- PBRER and aggregate report experience.
- Knowledge of medical and pharmacovigilance terminology.
- Understanding of GCP, GVP, ICH and USFDA guidelines.
- Knowledge of patient safety regulatory obligations.
- Good written and spoken English.
- Proficiency in MS Word, Excel and PowerPoint.
- Strong communication, organizational and teamwork skills.
6. Senior Clinical Data Co-ordinator
Location: Chennai, India
Qualification: Bachelor’s Degree in Pharmacy
Experience Level: Junior
Category: Clinical Research
Key Responsibilities:
- Coordinate day-to-day clinical data management activities.
- Oversee tasks assigned to study team members.
- Train new data management personnel.
- Plan and manage data processing and management activities.
- Develop study specifications and implement eCRF or paper CRF edit checks.
- Author and review Data Management Plans (DMPs).
- Design and review CRFs/eCRFs.
- Participate in database design and User Acceptance Testing (UAT).
- Review clinical data, issue queries and resolve discrepancies.
- Assist with medical coding discrepancies.
- Validate electronically captured data.
- Support quality control audits and clinical database integrity checks.
- Monitor clinical trial data flow and quality control processes.
- Maintain and archive clinical data management documentation.
- Assist with recruitment, interviews and candidate shortlisting.
Required Skills:
- Experience in Clinical Data Management.
7. Senior Regulatory Associate
Location: Chennai, India
Qualification: Bachelor’s Degree in Pharmacy
Experience Level: Junior
Category: Regulatory Affairs
Key Responsibilities:
- Publish, dispatch and archive regulatory submissions in agency-recommended formats.
- Support regulatory audits and compliance activities.
- Prepare submission-ready documents through formatting, hyperlinking and document processing.
- Maintain knowledge of regulatory agency standards and submission procedures.
- Troubleshoot technical issues in Adobe Acrobat and MS Word.
- Manage technical aspects and status updates for assigned submissions.
- Coordinate submission planning, publishing and quality control.
- Train and mentor junior team members.
- Assist in revising departmental SOPs, work instructions and training materials.
Required Skills:
- Experience in Regulatory Publishing and Submissions.
- Knowledge of publishing and validation tools.
- Proficiency in Adobe Acrobat and MS Word.
- Understanding of regulatory submission standards and procedures.
Eligibility and Qualifications
Candidates can apply based on the educational and experience requirements of individual positions.
- Pharmacy: B.Pharm or relevant postgraduate qualifications.
- Life Sciences: Graduate or postgraduate qualifications in relevant disciplines.
- Engineering: Relevant graduate qualifications for the Clinical Data Analyst position.
- Clinical Data Management: Experience in clinical data management for the Senior Clinical Data Co-ordinator role.
- Pharmacovigilance: Relevant knowledge of ICSR processing, aggregate reporting, GCP and GVP.
- Regulatory Affairs: Publishing and submissions experience for the regulatory positions.
How to Apply for Navitas Life Sciences Jobs?
Interested and eligible candidates can contact the Navitas Life Sciences recruitment team through the following email addresses:
India Recruitment:
recruitment.india@navitaslifesciences.com
Chennai Recruitment:
recruitment.chennai@navitaslifesciences.com
Bangalore Recruitment:
recruitment.bangalore@navitaslifesciences.com
Candidates should refer to the respective position’s eligibility and experience requirements when contacting the recruitment team.
