▷ [3 Days Left] Pharmacovigilance Medical Writer Ii
4 weeks 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
-
Pharmacovigilance Medical Writer II
1 week 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...
-
Pharmacovigilance Medical Writer II
6 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...
-
Pharmacovigilance Associate
2 weeks ago
Pune, Maharashtra, India Cliniweb Services Full timeCollect, review, and process adverse event reports from clinical trials and post-marketing sources. - Perform data entry of case details into safety databases accurately and within timelines. - Assist in coding adverse events, medical history, and medications using MedDRA and WHO-DD. - Support literature screening for identification of safety signals. -...
-
Pharmacovigilance Associate
6 days ago
Pune, India Bitwise Pharma Full timeJob description - Provide high quality, balanced and timely information to requests for medical information from both internal and external customers. - Maintain a database of Medical Information requests and responses. - Develop and maintain current knowledge of products and disease states. - Maintain references and other Medical Information resources. -...
-
Pharmacovigilance Associate
2 days ago
Andheri, Mumbai, Maharashtra, India Clariwell Global Services Full timeA pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision. - Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and...
-
Pharmacovigilance
2 weeks ago
Nagpur, Maharashtra, India Fusion Market Research Full time**Duties & Responsibilities**: 1. Establishment and Maintenance of the Clients’ Pharmacovigilance system for the products (PSMF); 2. Have an overview of medicinal product safety profiles and any emerging safety concerns, if possible; 3. Maintain awareness of Pharmacovigilance regulatory requirements and developments; 4. Identify, collect and report adverse...
-
Medical Writer Ii
2 days ago
Navi Mumbai, Maharashtra, India Fortrea Full time**Job Overview**: Lead writer responsible for preparation of clinical study protocols and clinical study reports (CSRs), and other clinical documents as needed. Provides support to more experienced writers with the preparation of complex clinical documents. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate....
-
Pharmacovigilance Associate
9 hours ago
Wakad, Pune, Maharashtra, India TechnoBridge Systems Pvt Ltd Full time**Responsibilities**: - Monitor and report adverse drug reactions (ADRs). - Prepare safety reports and ensure regulatory compliance. - Collaborate with healthcare professionals on drug safety. **Qualifications**: - Degree in Pharmacy, Life Sciences, or related field. - Knowledge of pharmacovigilance and medical terminology. - Strong analytical and...
-
Medical Reviewer Ii
1 week ago
Pune, India PrimeVigilance Full timeCompany Description We are PrimeVigilance (part of Ergomed PLC), 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 all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
-
Pharmacovigilance Associate
1 week ago
Shivajinagar, Pune, Maharashtra, India Fusion Technology Solutions Full time**Responsibilities**: - Process and assess individual case safety reports (ICSRs) - Enter and manage safety data in databases - Perform quality checks on safety reports - Assist in preparing regulatory reports (e.g., PSURs, DSURs) - Support signal detection and risk management activities **Skills Required**: - Knowledge of pharmacovigilance regulations...
