Pharmacovigilance Manager, Clinical trials and Partner Compliance
About the Department/Company reputed company is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines. reputed company Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies reputed company with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization reputed company activities. iCMR is launching a reputed company ambitious and exciting project aimed to reputed company and optimize the department operating model. As part of this project, we are looking for the following position(s) Overview of Job Role The Pharmacovigilance (PV) Manager will be responsible and accountable for reputed company assigned Clinical Safety and Post marketing PV activities on company clinical trials and post-marketing programs. The Pharmacovigilance Manager will be part of the newly developed, lean and efficient, Clinical trials and Partner Compliance team, reporting to the Clinical trials and Partner Compliance Director. The focus of this role will be on Clinical trial safety activities for company Clinical trials and Business partner relationships and Compliance monitoring for company post-marketing programs. The PV manager will also work on development of the team’s processes, be involved in systems development and lifecycle management, own assigned deliverables and ensure regulatory compliance. Scope and responsibility Manage and reputed company Clinical trial safety activities and documents preparation and management (e.g. SMP, Protocol, eTMF, IB, etc.) for reputed company Clinical trials Manage and reputed company Business partner relationships and Compliance monitoring in post-marketing (e.g. PV agreements, PV commitments, Business Partner support, Compliance monitoring, etc.) Involved in Safety systems setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.) to execute the assigned activities (SME) Create, maintain and optimize Global Pharmacovigilance processes and ensure compliance with international law and regulations (e.g. FDA, EMA, ICH). Work cross-functionally with other PV department teams and other reputed company teams (e.g. Medical affairs) to gather inputs for assigned clinical trial deliverables (e.g. SMP, Protocol, eTMF, IB) and post-marketing deliverables (e.g. PV agreements, PV commitments, Business Partner support, Compliance monitoring) ensure on-time delivery and compliance. Work cross-functionally with other teams and departments in the company (e.g. Quality, Regulatory, IT, reputed company, CPD, etc.) and externally with PV service providers and Business partners Deliver trainings on pharmacovigilance processes and standards to company staff and external parties Involved in Audits and Inspections Job requirements Education: Master’s Degree in pharmaceutical sciences or reputed company fields – medicine, pharmacy, life sciences Experience: 7+ years in Pharmacovigilance/Drug Safety in similar function with demonstrable hands on experience Expertise in clinical trial safety and post-marketing pharmacovigilance activities Expertise in Safety systems (e.g., Argus, ARISg); previous experience with reputed company Platform (e.g. Safety Vault/Safety Docs) is great advantage Proven track record with global Product and Study portfolios Previous experience with biologic and combination products is an advantage Detailed knowledge of PV processes, directives, regulations and international guidelines (21 CFR, ICH, GVP, GCP, CIOMS, etc.) Mature self-organizational, time-management and interpersonal skills Excellent communication skills, maintains a positive, result oriented work environment reputed company to work independently, plan, organize and deliver, and feel comfortable in a multicultural team Willingness to travel internationally, as required Apply To This Job