Regulatory and Pharmacovigilance Manager
Full-time Department: Regulatory and PV Network PrimeVigilance (part of Ergomed Group) is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America, and Asia covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We provide first-class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in our field. We cover all therapy areas, including medical devices. We invest in our staff by providing an excellent training and development platform. We value employee experience, well-being, and mental health, acknowledging that a healthy work-life balance is critical for employee satisfaction and nurtures an environment for high-quality client service. Join us in this exciting journey to make a positive impact in patients’ lives. Job Description The Manager, Regulatory and PV (Network) will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for regulatory and pharmacovigilance activities. The Manager will also act as Local Contact Person for the designated country. Job Responsibilities Assume leadership and functional representation for projects and/or deliverables of medium/high complexity, ensuring effective coordination and management of regulatory tasks. Develop strategy and manage setup activities (Project Management Plan, joint operating procedures, and core documents) ensuring compliance with department standards. Act as Local Contact Person for the designated country. Provide regulatory strategic input to internal and external customers and identify and address potential risks. Provide expert advice to clients addressing complex queries and changes in local regulations. Set up and coordinate the network of local contact persons (LCPs) for RA and PV in assigned projects. Ensure correct training assignment and compliance by the LCPs. Prepare and review client and vendor project invoices. Provide training, coaching, and mentoring to junior staff. Foster professional working relationships with internal and external contacts. Contribute to the Regulatory Newsletter and update the regulatory database. Ensure collection, QC review, and timely dissemination of all regulatory intelligence. Support client qualification activities and ensure audit readiness. Contribute to the assessment and qualification of new vendors. Assist in securing new business by participating in BDMs and developing regulatory sections of proposals. Drive department/company initiatives and manage implementation of changes. Minimum Requirements University degree in Biomedical sciences, Natural sciences, or Health Sciences (Nursing, Pharmacy, or equivalent advanced degree with relevant experience). Strong experience within the pharmaceutical or CRO industry or regulatory body, with demonstrated experience in a leading/project management role. Proven ability to manage global projects. Excellent organizational and management skills. Strong planning, strategizing, and problem-solving skills. Exceptional written and verbal communication skills. Outstanding interpersonal skills in a fast-paced environment. Remarkable attention to detail. Ability to manage multiple tasks and adapt to changing work assignments. Proficiency in English, both written and verbal. Proficiency in MS-Office applications (Word, Excel, PowerPoint). Why PrimeVigilance We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace. We believe our people are our greatest strength, leading to our continued success in improving the lives of those around us. We offer: Training and career development opportunities. Strong emphasis on personal and professional growth. Friendly, supportive working environment. Opportunity to work with colleagues globally, with English as the company language. Our core values are key to how we operate: Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging We look forward to welcoming your application.
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Full-time Department: Regulatory and PV Network PrimeVigilance (part of Ergomed Group) is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America, and Asia covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We provide first-class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in our field. We cover all therapy areas, including medical devices. We invest in our staff by providing an excellent training and development platform. We value employee experience, well-being, and mental health, acknowledging that a healthy work-life balance is critical for employee satisfaction and nurtures an environment for high-quality client service. Join us in this exciting journey to make a positive impact in patients’ lives. Job Description The Manager, Regulatory and PV (Network) will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for regulatory and pharmacovigilance activities. The Manager will also act as Local Contact Person for the designated country. Job Responsibilities Assume leadership and functional representation for projects and/or deliverables of medium/high complexity, ensuring effective coordination and management of regulatory tasks. Develop strategy and manage setup activities (Project Management Plan, joint operating procedures, and core documents) ensuring compliance with department standards. Act as Local Contact Person for the designated country. Provide regulatory strategic input to internal and external customers and identify and address potential risks. Provide expert advice to clients addressing complex queries and changes in local regulations. Set up and coordinate the network of local contact persons (LCPs) for RA and PV in assigned projects. Ensure correct training assignment and compliance by the LCPs. Prepare and review client and vendor project invoices. Provide training, coaching, and mentoring to junior staff. Foster professional working relationships with internal and external contacts. Contribute to the Regulatory Newsletter and update the regulatory database. Ensure collection, QC review, and timely dissemination of all regulatory intelligence. Support client qualification activities and ensure audit readiness. Contribute to the assessment and qualification of new vendors. Assist in securing new business by participating in BDMs and developing regulatory sections of proposals. Drive department/company initiatives and manage implementation of changes. Minimum Requirements University degree in Biomedical sciences, Natural sciences, or Health Sciences (Nursing, Pharmacy, or equivalent advanced degree with relevant experience). Strong experience within the pharmaceutical or CRO industry or regulatory body, with demonstrated experience in a leading/project management role. Proven ability to manage global projects. Excellent organizational and management skills. Strong planning, strategizing, and problem-solving skills. Exceptional written and verbal communication skills. Outstanding interpersonal skills in a fast-paced environment. Remarkable attention to detail. Ability to manage multiple tasks and adapt to changing work assignments. Proficiency in English, both written and verbal. Proficiency in MS-Office applications (Word, Excel, PowerPoint). Why PrimeVigilance We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace. We believe our people are our greatest strength, leading to our continued success in improving the lives of those around us. We offer: Training and career development opportunities. Strong emphasis on personal and professional growth. Friendly, supportive working environment. Opportunity to work with colleagues globally, with English as the company language. Our core values are key to how we operate: Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging We look forward to welcoming your application.
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