As a PV Professional, you will be responsible for ensuring patient safety by processing and managing serious and non-serious adverse events from post-marketing sources. The role requires a strong focus on data accuracy, medical coding, and case processing to ensure compliance with regulatory and safety standards.
Key Responsibilities:
- Case Processing: Process serious and non-serious adverse events from post-marketing sources.
- Medical Coding: Use MedDRA (Medical Dictionary for Regulatory Activities) to ensure accurate and consistent medical coding of adverse events in the Safety Database.
- Data Verification: Review and verify data from source documents to ensure the accuracy of suspect drug coding, seriousness, causality, and listedness.
- Follow-Ups & Queries: Collaborate with stakeholders to obtain correct and accurate data, ensure follow-ups, and transfer data to relevant parties.
- Quality & Process Stabilization: Analyze data for trending and assist in preparing the team for process improvements.
- Administrative Support: Manage day-to-day case processing activities and ensure compliance with work instructions and GVP modules.
- Internal/External Communication: Maintain effective communication with internal departments, partners, authorities, and vendors.
- Database Administration: Support Safety Database activities and procedural tasks as required.
- Compliance & Reporting: Ensure compliance with case timelines, assigned training, and provide analytical support during audits and inspections.
- Mentoring/Training: Mentor new hires on case processing and help evaluate their learning progress.
Qualifications:
- Education:
- M.Pharm / Pharm.D / BDS or Postgraduate degree in Life Sciences.
- Experience:
- 2 – 4 years of relevant experience in Pharmacovigilance, specifically in case processing and patient safety operations.
Key Skills:
- Proficient in using MedDRA for medical coding.
- Knowledge of GVP modules and Safety Database management.
- Strong attention to detail and ability to verify and analyze data.
- Effective communication skills for working with stakeholders.
- Experience in mentoring/training new team members.
