▷ [3 Days Left] Pharmacovigilance Medical Writer Ii
2 days ago
Company Description We are PrimeVigilance part of Ergomed Group a specialised mid-size pharmacovigilance service provider initially established in 2008 We are proud to have achieved global organic growth year after year with staff based across Europe North America and Asia all covering services within Medical Information Pharmacovigilance Regulatory Affairs and Quality Assurance PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields We cover all therapy areas including medical devices We love investing in our staff by providing an excellent training and development platform We value employee experience well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved We are looking for a pharmacovigilance medical writer to join our team The Medical Writer will be responsible for medical writing including PSURs PBRERs PADERs ACOs DSURs RMPs QC and review of all written output from the operations team as required Supporting the project managers to determine scheduling of the aggregate reports for which they are responsible In conjunction with the Quality Compliance and Training Manager identify areas for improvement and address via training clarifying changes to SOPs OGs templates Complete quality documentation of aggregate reports Attending kick off meetings with new clients as required Attending audits and inspections as required Providing aggregate report training Qualifications MD pharmacy or Life Science degree Masters or PhD is desirable Strong previous experience in Pharmacovigilance case processing signal detection or risk management within ideally a CRO environment Ability to manage multiple and varied tasks and prioritize workload with attention to detail Ability to effectively train and mentor Associate Medical Writers Must be a strong team player Fluency in English an additional language is a benefit Additional Information Why PrimeVigilance We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow To succeed we must work together with a human first approach Why because our people are our greatest strength leading to our continued success on improving the lives of those around us We offer Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly supportive working environment Opportunity to work with colleagues based all over the world with English as the company language Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join Quality Integrity Trust Drive Passion Agility Responsiveness Belonging Collaborative Partnerships Come and join us in this exciting journey to make a positive impact in patient s lives We look forward to welcoming your application
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Pharmacovigilance Medical Writer II
5 days ago
Pune, Maharashtra, India Ergomed Full time ₹ 5,00,000 - ₹ 12,00,000 per yearCompany Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...
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Pharmacovigilance Medical Writer II
2 weeks ago
Pune, Maharashtra, India Ergomed Full time ₹ 8,00,000 - ₹ 24,00,000 per yearCompany Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...
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Pharmacovigilance Medical Writer II
3 days ago
Pune, Maharashtra, India Primevigilance Full time ₹ 9,00,000 - ₹ 12,00,000 per yearCompany DescriptionWe are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...
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Pune, India Fortrea Full timeJob Description Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary Of Responsibilities - Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event...
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Pharmacovigilance Associate
60 minutes ago
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Pune, Maharashtra, India Statistical Pharma Full time**Primary Responsibilities**: 1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. -...
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Pharmacovigilance Associate
1 week ago
Pune, India Statistical Pharma Full time**Primary Responsibilities**: 1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. -...
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Pharmacovigilance Associate
2 days ago
Pune, India Statistical Pharma Full time**Primary Responsibilities**: 1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. -...
