We are looking for a highly skilled Safety Specialist II to join our growing team. The ideal candidate will be responsible for compiling and analyzing safety data to prepare various Aggregate Safety Reports, signal management, and risk management activities. This role offers an exciting opportunity to work in a dynamic and collaborative environment with a focus on safety and compliance within pharmacovigilance.
Key Responsibilities:
- Aggregate Reports:
- Author and review Aggregate Safety Reports, including DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports, according to project requirements.
- Review and analyze aggregate safety data from databases, generating line listings (LL) and summary tabulations (ST).
- Ensure that reports align with client specifications and timelines, and incorporate feedback from both internal and external reviewers.
- Conduct literature screening to identify significant safety articles for inclusion in the reports.
- Compile benefit-risk evaluation sections based on input from medical reviewers.
- Actively participate in internal and external audits by clients and health authorities.
- Signal Management and Risk Management Plans:
- Screen, mine, and tabulate safety data to detect potential signals using industry-standard signal detection tools.
- Draft signal detection, validation, assessment, and benefit-risk analysis, and prioritize identified signals.
- Ensure compliance with signal detection SOPs, conventions, and guidelines.
- Monitor the status of identified signals (e.g., potential, open, refuted, validated signals).
- Assist in developing and updating Risk Management Plans in compliance with client-specific SOPs.
- Collaboration and Support:
- Assist in the scheduling of assigned reports and manage workloads for the team.
- Provide support to the Individual Case Safety Report team and Literature Review team as needed.
- Maintain effective communication with internal and external stakeholders to ensure the timely completion of tasks.
Desirable Skills and Experience:
- Proven experience in authoring and reviewing Aggregate Safety Reports, particularly PBRERs.
- Strong understanding of medical and pharmacovigilance terminologies.
- Knowledge of GCP, GVP, ICH, USFDA guidelines, and other pharmacovigilance-related regulations.
- Competency with medical and therapeutic terminology.
- Familiarity with regulatory obligations surrounding patient safety.
- Good working knowledge of office software (MS Office: Word, Excel, and PowerPoint).
- Strong communication skills in both written and spoken English (additional languages a plus).
- Excellent organizational, motivational, and teamwork abilities.
Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
- Relevant experience in pharmacovigilance or safety reporting.
- Additional certifications in pharmacovigilance or regulatory affairs are a plus.
Why Join Us?
- Work with a dynamic team in a growing company.
- Competitive salary and benefits package.
- Opportunity for career growth and development within the pharmacovigilance field.
To Apply:
Please send your resume and cover letter to recruitment.bangalore@navitaslifesciences.com