Senior Manager, Safety Scientist (Lexington)

Compensation

: $94,360.00 - $141,170.00 /year *

Employment Type

: Full-Time

Industry

: Non-Executive Management



Position Summary

This position is responsible for the execution of the deliverables for the Global Pharmacovigilance (GPV) Safety Study Management Team. The GPV Scientist plays a pivotal role within Global Pharmacovigilance to ensure safety assessment for all Alexion products. This person will provide scientific and compliance expertise as needed to GPV according to Alexion PV SOPs and standards and will be a key member of core study team representing GPV Operations.

Job Duties & Responsibilities

Responsibilities for this role include, but are not limited to:

  • Serve as a member of Global development and post approval core teams subcommittee & teams
  • Collaborates with other Alexion departments and vendors to ensure data collection, analysis and reporting in Alexion interventional, non-interventional trials and IIT/ISR is in compliance with global regulatory requirements and Alexion SOPs
  • Serves as an expert on pharmacovigilance global regulations, guidelines and industry best practices
  • Ensures compliance with health authority regulations with regards to data collection, analysis, reporting standards and operational consistency across interventional and non-interventional trials
  • Performs initial analysis and writing of the safety section of Alexions protocols and other safety related documents in collaboration with RMLs
  • Collaborates with Clinical Operations, Data Management, Clinical CRO and Study Teams in development of the safety related data collection forms, table design, and listings for safety data from interventional/non-interventional trials
  • Reviews and provides input and support with other departments (e.g., clinical operations, medical information, regulatory affairs, medical affairs, commercial CRO and data management) groups on safety/PV related topics for study protocols, statistical analysis plans and other clinical related documents
  • Writes the safety section in collaboration with team members on regulatory responses, IBs/CCDS, study protocols, CRFs, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control
  • Works directly with and supports the PV safety physicians (RMLs) in data collection and assessment needs for SMTs, CSRs, GSC, PBER, DSUR and ad hoc requests, etc.
  • Ensures compliance and quality are maintained and issues are escalated appropriately and resolved
  • Authors Safety Assessment Reports and other safety documents (e.g., regulatory request, Data Monitoring Committees, IBs and CRFs) in collaboration with the Global Safety Physicians
  • Runs/supports routine signal detection processes in partnership with RML for assigned products and and writes up the analysis results
  • Works with RML to prepare agenda, presentations and minutes for Safety Management Team meetings.
  • Prepares presentation of the Global Safety Teams recommendations on safety issues to the cross-functional decision-making bodies
  • Supports Safety Physicians or RMLs in the development of risk management strategy and activities: Provides content for safety aspects of risk management plansAssists the RML with project management of the safety aspects of global risk management plansDevelops or updates strategy and content for regional risk management plansAssists Safety Physicians to oversee risk minimization activities including tracking of activities as neededAssists in the evaluation of risk minimization activityAssist with responses to regulatory inquiries related to risk management plans under the guidance of global safety physicians
  • Supports activities related to new drug applications and other regulatory filings Assists Global Safety Physicians in developing a strategy for safety-related regulatory activitiesProvides safety contents for filings
  • Assists with the execution of CAPAS to minimize compliance gaps with the remit of role and responsibility
  • Performs other duties related to the position as necessary as defined in SOPS and/or as request by Supervisor
  • Serve as a SME for pre and post approval inspection for the studies/products under their responsibility
  • Essential Qualifications

  • Minimum: Pharmacist/PharmD or BS/Masters in Nursing with a minimum of 3 years of clinical experience
  • Minimum 8 years of related experience supporting PV in a pharmaceutical environment required
  • Demonstrated proficiency in global regulatory requirements, guidelines and industry best practices for pharmacovigilance with experience in safety related organized data collection, analysis and reporting (e.g., interventional and non-interventional clinical trials, registries, patient programs, market research programs)
  • Expertise with PV clinical and safety databases (e.g., structure and conventions)
  • Experience in MedDRA coding and search strategies
  • Strong people and project leadership skills
  • Strong organizational and prioritization skill
  • Excellent analytical and problem solving sills
  • Excellent communication skills, oral and written, including medical / scientific writing
  • Experience in safety data analysis and writing study related aggregate reports and safety assessments
  • Literature search, evaluation and assessment skills
  • Presentation skills for conveying complex technical contents to non-expert audience
  • Demonstrated commitment to quality and compliance
  • Demonstrated learning agility and ability to work independently, seeking advice as required
  • Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
  • Expertise with Microsoft Word, PowerPoint, SharePoint and Excel
  • Understanding of clinical development processes related to clinical trials preferred
  • Preferred Qualifications

  • BS Nursing, Masters Degree or RPh/PharmD

  • Associated topics: dietary, drug, food, kinesiology, microbiological, pharmaceutical, pharmacology, therapeutic, therapy, vaccine * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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