Are you passionate about ensuring drug safety and patient well-being? Bridgewest Group is looking for a qualified and experienced Safety Scientist to join our team and make an impactful contribution to pharmacovigilance efforts. If you’re ready to take the next step in your career, read on to learn more about this exciting opportunity!
About Bridgewest Group
Bridgewest Group is a dynamic global firm known for its contributions to pharmaceuticals, biotechnology, and various consulting services. We take pride in supporting healthcare advancements and ensuring drug safety across pre- and post-market stages. Our commitment to regulatory excellence has helped us become a trusted partner in the industry.
Key Responsibilities
As a Safety Scientist, you’ll play a pivotal role in managing Individual Case Safety Reports (ICSRs) and other critical pharmacovigilance activities. Responsibilities include:
- ICSR Management: Oversee all ICSR stages, including intake, triage, data entry, quality review, and submission for both pre-market and post-market reports.
- Literature Surveillance: Conduct ongoing literature reviews across PubMed, EMBASE, and other medical databases to identify new safety information.
- Signal Detection: Forward abstracts with safety data to the signal detection team to support aggregate safety reporting.
- Case Follow-Up: Generate follow-up letters and questionnaires to ensure comprehensive data for each case.
- Aggregate Reporting: Prepare Periodic Benefit-Risk Evaluation Reports (PBRER) and manage safety surveillance processes.
- Database Setup and Maintenance: Assist in database configuration and manage the safety mailbox for efficient case handling.
- PSMF Maintenance: Support the maintenance of the Pharmacovigilance System Master File (PSMF).
- QPPV Support: Assist in Qualified Person for Pharmacovigilance (QPPV) office responsibilities.
- Regulatory Intelligence: Track relevant safety literature and ICSRs to align with regulatory requirements.
- Eudravigilance Maintenance: Maintain Eudravigilance profiles as per EU pharmacovigilance standards.
- SOP Drafting: Develop and maintain Standard Operating Procedures (SOPs) that reflect best practices and regulatory compliance.
Required Qualifications
To excel as a Safety Scientist at Bridgewest Group, candidates must meet the following qualifications:
- Educational Background: M.Pharm or Pharm D with relevant pharmacovigilance experience in the pharmaceutical industry.
- Experience: 4-6 years in drug safety and pharmacovigilance, ideally involving both investigational and marketed products, within pharmaceutical or biotech companies, or consulting firms.
Skills and Competencies
- Drug Safety and Pharmacovigilance: Strong understanding of ICSR management and regulatory requirements for drug safety.
- Regulatory Knowledge: Familiarity with Eudravigilance, regulatory intelligence activities, and aggregate report preparation.
- Attention to Detail: Precision in data entry, triage, and quality review of safety reports.
- Communication Skills: Clear, concise, and professional communication for follow-up letters and safety documentation.
- Technical Proficiency: Ability to navigate pharmacovigilance databases and maintain accurate safety records.
How to Apply
If this role aligns with your expertise and career goals, we invite you to apply! Please send your updated CV or resume to cshaik@bridgewestgroup.com.
