Pharmacovigilance Analyst III
- Responsible and accountable for all aspects related to the handling of safety information originating from post-marketing, clinical trials, literature, and other sources.
- Investigation, documentation, medical research, and processing of incoming Adverse Drug Events (ADEs) or Reactions (ADRs) as per Alexion’s SOPs.
- Reviews cases for expectedness and seriousness.
- Maintains in-depth knowledge of the assigned projects, regulatory requirements, and other safety-related initiatives.
- Supports the team on safety-related issues.
- Contributes to regulatory responses, IBs, study protocols, CRFs, Reports, and other documents as required.
- Reviews and assesses data to identify potential safety related signals
- Retrieves information from the safety database for use in aggregate safety reports for dissemination to PV and to fulfill regulatory compliance.
- Works as an effective team member in Global PV Group
- Collaborates with GPV Group on effective processes with 3rd parties for any outsourced activities
- Work closely with safety physician and support the data collection and assessment needs for SMTs, CSRs, GSC, Adhoc requests etc.
- Effectively triages cases based on seriousness and expectedness
- Responsible for providing quality documentation of safety data, particularly serious adverse events (SAEs), through direct contribution in a matrix environment.
- Ensures compliance with health authority regulations in all aspects of drug safety data processing and reporting.
- Processes SAEs from receipt to case closure in the safety database including query generation.
- Conducts follow-up to obtain critical or missing AE information for appropriate medical assessment.
- Compilation of Safety Reporting Plan covering SAE workflow between CRO and ALXN
- Collaborates with team members on the development and implementation of PV standard operating procedures (SOPs)
- Maintains and updates documentation of personal training records
- Oversees electronic and hard copy document management, retrieval, and archiving of PV information including individual case summary reports to partners, CROs, and health authorities
- Reviews and reconciles SAE data between clinical and safety databases
- Interacts with clinical operations, medical information, regulatory affairs, commercial, CRO and data management groups on PV related issues for assigned study protocols
- Remains informed of all appropriate current health authority regulations and guidance, including those from ICH
- Collaborates with team members on regulatory responses, IBs, study protocols, CRFs, Reports, and other documents as required
- Support safety physician in data collection and assessment needs for SMTs, CSRs, GSC, Adhoc requests etc.
- Support unblinding procedure for blinded trials
- Develop Safety Reporting Plan for the clinical trials assigned and work with CRO supporting the study on process implementation
- Ensure Clinical Trail activities are being performed as per SRP & protocol
- Identify quality issues & trends and notify appropriate team leader
- Perform quality check on ICSR’s
- Relies on experience and judgment to plan and accomplish goals.
- Participate in the process improvement effort in developing, implementing, and documenting all PV training, conventions and training other team members and CROs with respect to ALXN data collection conventions
- Responsibility for trains fellow Alexion colleagues and vendors on appropriate adverse event reporting
- Minimum 3 years’ of industry experience
- Minimum of 3 years’ clinical safety experience or 5+ years of relevant experience in the healthcare, clinical or bio-pharmaceutical field, or other related experience; direct experience in a pharmaceutical or biotechnology company Drug Safety Department preferred
- Good understanding of drug development, Drug Safety requirements and health authority regulations for adverse event reporting, and working knowledge of the importance of regulatory compliance
- Strong computer and database skills, experience with PV databases; ARGUS database experience a plus
- Strong organizational, oral/written communication and project management skills
- Attention to detail and a high commitment to the quality of all projects and accountability for deliverables
- Demonstrated ability to manage multiple projects and prioritize
- Ability to solve complex problems and suggest creative solutions
- Proactive, positive approach to projects and constructive, interactions with colleagues
- Natural Science degree with minimum of 3 years’ of clinical safety/CRA or health science experience.
- Health Care degree preferred
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