Safety Risk Management Lead

Role Summary

Safety Risk Management Lead provides safety expertise, pharmacovigilance, and safety risk management for assigned products (marketed or in development). S/he will perform ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.

Responsibilities

• Lead safety signal management activities including data preparations and presentations.
• Assist GPS GSLs in their assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders internally.
• Prepare data for and actively participate in safety governance and risk management processes including safety management teams (SMT) and benefit-risk committees (BRC).
• Effectively lead, oversee and participate in the planning, preparation and review of periodic reports (DSUR, PSUR, PADER).
• Participate in the presentation and analysis of safety data from on-going and completed clinical trials.
• Review and provide safety input, as needed, for key study-related documents, e.g., Investigator‚Äôs Brochure (IB), Informed Consent Form (ICF), Independent Data Monitoring Committee (IDMC) Charter.
• Participate in protocol development and review, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans, as needed.
• Participate in departmental development activities including SOP and Work Instructions development.
• Perform other activities as needed to assist with departmental activities.

Skills

• Knowledge of pharmacovigilance as applies to safety signal management, safety data review in clinical and post-marketing settings
• Knowledge of relevant global pharmacovigilance regulations and guidelines
• Ability to prepare and/or review high quality safety documents, including periodic aggregate safety reports, signal evaluation report, or risk management plans
• Ability to communicate complex issues effectively
• Ability to influence and collaborate with multidisciplinary teams
• Ability to prioritize and plan proactively
• Excellent analytical and problem-solving skills, with sound autonomy and applied judgment
• Experience with MedDRA, WHO Drug Dictionary
• Understanding of the principles of databases, querying data sources as well as developing and applying search strategies
• Relevant computer skills including proficiency with Microsoft Office
• Fluency in written and spoken English

Education

• Bachelor‚Äôs or Master‚Äôs degree in pharmacy, nursing, healthcare or other life sciences or technical fields (Ph.D. or M.D. a plus)

Experience And Qualifications

• Minimum of 7-10 years of relevant pharmaceutical/biotech industry or healthcare experience
• Pharmacovigilance/safety risk management experience is strongly preferred