Manager, Pharmacovigilance Special Consulting Services

Job Description: • Case Management Individual Case Safety Report (ICSR) assessment of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; decision on expedited reporting; reporting of ICSRs to the competent authorities. • Data entry quality control, including case assessment. • Oversight of team Pharmacovigilance activities including ICSR reporting, reconciliations, follow up requirements, literature screening, signaling, inquiry and complaint management. • Communication with regulatory authorities and clients regarding all pharmacovigilance-focused aspects. • Participation, reviewing and approval of safety update reports PSURs (Periodic Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports) DSURs (Development Safety Update Reports), risk management plans and signal detection reports required and in support of risk-benefit profiling. • Writing/Review of procedural documents such as Working Instructions, SOPs, Working Procedures, Templates etc. for PharmaLex PV projects. • Overview of needed resources for their projects, and inform their Manager on an ad hoc basis. • Review of Pharmacovigilance Intelligence Reports and perform gap analysis/impact assessment on own processes. • Training of staff in selected areas of pharmacovigilance and client specific activities and requirements. • Act as a mentor to colleagues new in their roles or new in various projects/tasks. • Proactive in suggesting improvements to the services offered to our clients in the SCS service line. • The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required. Requirements: • Life sciences degree preferred but not essential • Several years’ experience and profound knowledge in the field of pharmacovigilance • Expertise, experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance • Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads) • Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope • Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level • Good communication skills (written and verbally); capability to communicate issues and propose appropriate solutions to decision makers • Good presentation skills. Benefits: • medical, dental, and vision care • a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness • support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave • variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more Apply tot his job