Are you a recent graduate with a passion for drug safety? Navitas Life Sciences is hiring freshers for exciting opportunities in pharmacovigilance. If you hold a degree in B.Pharm, M.Pharm, PharmD, or BDS and are enthusiastic about starting a career in this vital area of the pharmaceutical industry, this is your chance.Navitas Life Sciences is a global organization that offers a range of services in the life sciences sector, particularly in the fields of clinical research, pharmacovigilance, data management, and consulting. They focus on providing end-to-end services that support the development, approval, and post-marketing surveillance of pharmaceutical products and medical devices. Navitas Life Sciences aims to accelerate product development and ensure regulatory compliance through innovative solutions and deep industry expertise.Their services often include clinical trial management, regulatory submissions, safety monitoring, real-world evidence generation, and more. The company is known for leveraging technology and data analytics to optimize the efficiency and effectiveness of their operations.
Job Details :
- Position Name : Pharmacovigilance Fresher
- Organization : Navitas Life Sciences
- Qualification: B.Pharm, M.Pharm, Pharm.D, BDS, Lifesciences
- Experience: 0 YEARS / Freshers
- Salary: 25,000 – 35,000 /month
- Location: Chennai, Bangalore
Job Description :
Key Responsibilities:
- Adverse Event Reporting:
- Collect, document, and report adverse drug reactions (ADRs) from various sources such as clinical trials, post-marketing surveillance, and spontaneous reports.
- Case Processing:
- Review and process individual case safety reports (ICSRs), ensuring accurate data entry, assessment, and narrative writing.
- Classify adverse events according to severity, seriousness, and expectedness.
- Regulatory Compliance:
- Ensure adherence to global regulatory guidelines, including Good Pharmacovigilance Practices (GVP), and local regulatory requirements.
- Prepare and submit periodic safety update reports (PSURs) and other regulatory documents.
- Safety Surveillance:
- Conduct literature reviews and assess new safety information from scientific publications, clinical trials, and other sources.
- Cross-functional Collaboration:
- Work closely with other departments, including clinical research, regulatory affairs, medical affairs, and data management, to ensure comprehensive safety monitoring.
- Training and Development:
- Provide training on pharmacovigilance practices and regulations to internal teams and external partners.
- Stay updated with the latest pharmacovigilance guidelines, regulations, and industry trends.
Required Skills and Qualifications:
- Educational Background:
- A degree in life sciences, pharmacy, medicine, or a related field. Advanced degrees (e.g., PharmD, MD) are often preferred.
- Experience:
- Prior experience in pharmacovigilance or drug safety, particularly in case processing, regulatory reporting, and safety surveillance.
- Technical Skills:
- Analytical Skills:
- Communication Skills:
- Attention to Detail:
Key Contributions:
- Adverse Event Sentinel:
- Act as the first line of defense by vigilantly capturing and documenting adverse events, ensuring that no potential risk to patient safety goes unnoticed.
- Architect of Safety Signals:
- Utilize advanced analytical techniques to detect subtle patterns within complex datasets, identifying emerging safety signals before they become widespread concerns.
- Drive the strategic evaluation of these signals, collaborating with cross-functional teams to proactively mitigate risks.
- Global Compliance Navigator:
- Expertly navigate the intricate web of global regulatory requirements, ensuring that every adverse event report and safety update is compliant with the latest standards.
- Safety Data Strategist:
- Contribute to the development and refinement of Risk Management Plans (RMPs), playing a pivotal role in shaping the safety strategies that govern the use of pharmaceuticals.
- Cross-functional Safety Advocate:
- Serve as the voice of pharmacovigilance within multidisciplinary teams, advocating for patient safety in every decision, from clinical trial design to post-marketing surveillance.
- Inspection-Ready Steward:
- Prepare the organization for pharmacovigilance audits and regulatory inspections, ensuring that all safety processes are robust, transparent, and in full compliance with global standards.
How To Apply :
Send your updated CV to: recruitment.bangalore@navitaslifesciences.com.