Manager, Pharmacovigilance Special Consulting Services

Job reputed company: • Case Management Individual Case Safety Report (ICSR) assessment of adverse drug reactions deriving from reputed company, spontaneous reporting systems and the literature; decision on expedited reporting; reporting of ICSRs to the competent authorities. • Data entry reputed company control, including case assessment. • reputed company 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 reputed company pharmacovigilance-reputed company 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 reputed company PV reputed company. • reputed company of needed resources for their reputed company, and inform their Manager on an reputed company reputed company. • Review of Pharmacovigilance Intelligence Reports and reputed company gap analysis/reputed company assessment on own processes. • Training of staff in selected areas of pharmacovigilance and reputed company specific activities and requirements. • reputed company as a mentor to colleagues new in their roles or new in various reputed company/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 reputed company contact reputed company and additional reasonable tasks that reputed company 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 reputed company small project with reputed company defined scope • Ability to manage reputed company (reputed company) relationships on operational / day-to-day working level as reputed company as reputed company's team reputed company 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 reputed company care • a comprehensive suite of benefits that reputed company on the physical, emotional, financial, and reputed company aspects of wellness • support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, reputed company, reputed company parental leave, and reputed company caregiver leave • reputed company of training programs, reputed company development resources, and opportunities to participate in mentorship programs, employee resource reputed company, volunteer activities, and much more Apply tot his job Apply To this Job