Global Safety Lead (GSL) Pharmacovigilance will act as Global Safety Leader for an assigned portfolio of marketed products and products in development. The GSL is responsible, with limited supervision, for all medical aspects of safety assessment and the safety risk management strategy of products in every stage of product life cycle worldwide. The GSL will serve on relevant inter-departmental teams representing Medical Affairs.
ESSENTIAL FUNCTIONS : Perform medical assessment of individual case safety reports including seriousness, expectedness/listedness, causality and additional follow up for both post-marketing surveillance and clinical studies. Author and/or review and approve all aggregate safety reports including PSUR, DSUR, RMP/REMS, and response documents to inquiries from world-wide regulatory agencies. Responsible for safety aspects of clinical trials including evaluation and interpretation of appropriateness of safety monitoring and information collection in protocol and case report form, company/sponsor evaluation on individual AE reports, safety findings for Investigational Brochure, clinical study reports, summary of clinical safety, risk and benefit assessments and product labeling in regulatory submissions. Lead safety signal management throughout product lifecycle including signal detection, , evaluation, validation and development of risk management strategies. A GSL takes the initiative to evaluate all safety triggers and thresholds and potential safety signals resulting from both quantitative and qualitative methods. Prioritize signals according to public health impact then evaluate them in timely fashion. A. Comprehensive review of all available safety data including current and historical medical and scientific literature, the global safety database and relevant clinical trial data.
Assessment of the causal association between a product-event pair, using current threshold criteria. Safety results are periodically presented and defended before a management review panel (Safety Action Committee). Following approval of signals, the GSL leads the formation of a Label Working Group to plan public communication planning for new safety findings. Lead the initiation of Company Core Safety Information (CCSI) working groups. CCSI WG may update existing CCSI with new safety findings or create a new CCSI; Develop project plans and timelines to support CCSI WG activities; Draft CCSI revisions and support documentations by leading a multidisciplinary team in coordination with Regulatory Affairs Serve as safety expert on inter-departmental teams to assess patient safety impact arising from deviation from product quality specifications by performing Health Hazard Evaluations and by contributing to Corrective Action and Preventative Action Plans (CAPA).
Communicate effectively and timely on safety and benefit/risk assessment, risk analyses, communication, mitigation, and minimization to internal and external stakeholders. Lead or contribute to project and/or process improvements that support overall strategic safety objectives. Mentor and support on-boarding trainings of new colleagues. Develop and maintain comprehensive and up-to-date knowledge of the assigned product portfolio and regulations for safety reporting and surveillance. Develop and maintain audit/inspection readiness for GSL function; Assist in internal and external audits/inspections for Medical Safety for pharmaceuticals and medical devices as needed.
MINIMUM REQUIREMENTS: Education: MD/DO or international equivalent (does not need to possess an active US medical license but must not appear on any suspended license list)
Experience: 8 years total combined industry/clinical experience A minimum of 2 years of Pharmacovigilance experience in Clinical Safety or Post-Marketing Safety including thorough knowledge of FDA and ICH safety reporting regulations and guidelines. Any experience with regional, national and global regulatory authority is a plus. Experience in aggregate reporting, signal detection and ARGUS required
Preferred Skills/Qualifications: Advanced analytical skills Sound medical judgment and decision making capabilities Strong oral and written communication skills Strategic thinking and facilitative leadership Fluent utility of office computer programs such as Excel, Word, and PowerPoint Formal training in Epidemiology a plus Sound organizational and prioritization skills Demonstrated skills for project management Direct Reports: None Interact with: Legal Affairs, Regulatory Affairs, and R & D, IS, Sales and Marketing and other groups with varying degree and scope.