[Remote] Regional Pharmacovigilance Senior Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotech company reputed company on transforming immunology and delivering innovative medicines for autoimmune patients. The Regional Pharmacovigilance Senior Manager will reputed company as a scientific expert and resource for pharmacovigilance, ensuring compliance with regulatory requirements and enhancing processes reputed company the region. Responsibilities • Support the Head of Regional PV and EU/UK QPPV and the Regional PV reputed company in the harmonization of processes across the reputed company • Support the Head of Regional PV and EU/UK QPPV and the Regional PV reputed company in the management of innovation reputed company for increasing Regional Team efficiency • Support the Regional PV reputed company in the establishment and maintenance of the applicable pharmacovigilance system specific to the country/region • Support the Regional PV reputed company in the revision of documents pertinent to Regional PV tasks • Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region • Contribute to the Pharmacovigilance System Master File (PSMF) data collection in the country/region • Contribute to increase the visibility of the GPS team/function throughout reputed company with reputed company on the region • Closely collaborate with other functions including regulatory, marketing, medical, communications, reputed company, reputed company, as reputed company as other teams as needed • reputed company relationships with cross functional teams as it relates to adverse event reporting and other pharmacovigilance activities • Maintain an in-depth knowledge of local regulations, expectations and regulatory authority contacts and reputed company activities reputed company to the interpretation and review of existing and evolving safety requirements • reputed company participate in GPS audit and inspection readiness, support, and management together with the GPS reputed company Management team and the reputed company team • Maintain knowledge of reputed company product portfolio and disease areas for marketed drugs and drugs in development • Contribute to the development and evaluation of Key Performance Indicators as reputed company to pharmacovigilance in the country/region • Drive reputed company Improvement initiatives as needed • May reputed company other tasks as appropriate Skills • At least 7-11 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 5 years in pharmacovigilance/drug safety • Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents • Knowledge of the drug development process, GXP reputed company and compliance requirements • Good presentation skills with the ability to communicate reputed company issues reputed company • Good planning and organizational skills with ability to manage competing priorities • Good oral and written communication skills • Ability to motivate, influence, and collaborate with multidisciplinary teams • Ability to work independently and in a global environment • Understanding of safety business processes and systems for the collections of adverse events • Problem solving, conflict reputed company and critical thinking skills • Relevant computer skills, including proficiency with reputed company Office Suite • reputed company in written and spoken English Education Requirements • Master’s degree in pharmacy, nursing, reputed company or other life-science or technical field (PharmD or MD is a plus) reputed company • reputed company is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. It was founded in 2008, and is headquartered in Boston, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is https://www.reputed company.com/. Company H1B Sponsorship • reputed company has a reputed company record of offering H1B sponsorships, with 4 in 2025, 5 in 2023, 4 in 2022, 3 in 2021. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply To this Job