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Pharmacovigilance Scientist

Posted 21 days ago

  • Expiry Date: 26 May 2022

Job Description:

  • Research and Development / Global Regulatory, Safety and Biometrics /Worldwide Patient Safety/Epidemiology, Safety Science Capabilities and Innovation (ESSCI)

  • The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

  • Supports Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Independently performs core signal detection activities and elevate program or portfolio issues impacting key Safety Management Team (SMT) programs, priorities, resources, and milestones. Authors safety data query responses, author and contribute to specific PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR).

  • Ensures pharmacovigilance regulatory compliance.
    Mentors less experienced scientists and teams in aspects of project management, SMT requirements, core signal detection, safety data query responses, and contributions to specified PV sections of the PBRER and DSUR, as appropriate to meet individual or group of SMT/subteam needs.

General Product Support:

  • Collaborates with Medical Safety Assessment Physician (MSAP) leading signal detection activities for a products emerging safety profile.
    Provides strong medical writing support for PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyzes data for the RSI section of the IB. Collaborates with MSAP to author and analyze data for ad hoc responses to health authorities.

  • Contributes to the development of the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Documents signal by Safety Topic Review/ Signal Report.

  • Analyzes data and prepare documentation to support label updates for assigned products.

  • Supports Safety for input to regulatory product labeling.

  • Supports the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products.

  • Applies knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities.

  • Share with individuals and teams on these applied learnings.

Clinical Development & Post Marketing Product Support:

  • Leads core surveillance activities, signal assessment according to the product stage of development for multiple compounds, with oversight, as needed.

  • Leads Safety Data Review (SDR) Teams in the review and evaluation of clinical data to support signal detection. Appropriately elevates issues impacting key SMT activities, milestones, and documents to the SMT Chair with limited or no oversight, as needed.

  • Contributes to specified PV sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with limited or no oversight, as needed.

  • Provides guidance to junior scientists for reviewing and authoring of safety data/ad hoc queries.

  • Contributes to the strategy and perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.

  • Provides input for the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database).

  • Partner with SMT Chair on the evaluation & management of signals emerging from any data source.

  • Authors the Safety Topic Review/ Signal Report and tracks signals for other means of communication, with limited or no oversight, as needed.

  • Facilitate the review and evaluation of SARs for inclusion in the IB RSI, including presentation to SMT to ensure alignment.

  • Author the IB RSI table for multiple products with limited or no oversight.

  • Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, with limited or no oversight.

Department Activities:

  • Participates in improvement projects. Assist the PV scientist team Lead in developing and maintaining state-of-the-art PV processes and procedures within R&D and WWPS.

  • Supports preparation for regulatory inspections and audits for evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.

  • Assists the team and senior management in all forms of issue management and crisis management.

  • Liaises with all TA staff and maintain an effective and collaborative safety team.

  • Supports hiring & orientation.

Cross Functional Activities:

  • Supports process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.

  • Supports the development of strategic plans for safety differentiation of products.

  • Builds cross functional relationships with SMT membership and stakeholders.

Leadership Behaviors:

  • Proficient

  • Seek feedback and best practices for continued development

  • Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience.

  • 6 - 8 years relevant Pharmacovigilance/Pharmaceutical Industry experience; Ability to mentor others.

  • Partners with Medical Safety Assessment Physician (MSAP) to plan, lead, and advance programs.

  • Good working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.

  • Good working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills.

  • Appropriately communicates items that could impact timelines or quality.

  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)

  • Ability to work well in cross-functional teams.

  • Routinely takes initiative

  • Ability to collaborative and communication skills with scientific subject matter.

  • Ability to make good decisions based upon a mixture of analysis, knowledge, experience, and judgment.

  • Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions.

  • Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, post marketing reports, scientific literature, and regulatory documents).

  • Good understanding aspects and methods for data analysis, interpretation and presentation.

  • Possess good working skills in MS Word, Excel and PowerPoint, including statistics.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.