Pharmacovigilance Analyst III

Alexion

Job Description

Position Summary 

  • 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.

Principal Responsibilities 

  • 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

Qualifications 

  • 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

Education           

  • Natural Science degree with minimum of 3 years’ of clinical safety/CRA or health science experience.
  • Health Care degree preferred

*LISM-1

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