Local Contact Person For Pharmacovigilance And
hace 2 semanas
col-wideJob Description:Company DescriptionPrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK. The company boasted 40% growth in its revenues in its last report.This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients.Job Description**KEY ACCOUNTABILITIES**:The LCPPV/LCPRA is responsible for supporting with local PV/RA services. They provide franchise liaison between Ergomed Plc/ PrimeVigilance and client on a multiple projects' program. They also provide strategic/advisory guidance to other members of the RA & PV Network team**LCPPV responsibilities**:- Primary contact person for local regulatory authority / Pharmacovigilance expert as per local requirements- Prompt and effective communication with local regulatory authorities- Provision of local regulatory intelligence screening- Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)- Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues- Support audits and Inspections**LCPRA responsibilities**:- Contact point for NCA- Assistance with local RA portals (if applicable for the country)- Participation on local administrative documents for submission- Review and linguistic input on local Product Information and Mock-ups- Collecting RA Regulatory Intelligence- Ad hoc local regulatory advice- Attending teleconferences- Reporting RA activities to the Client electronically**Local Literature Screening (if applicable)**- Perform local non-indexed literature screening and screening of Regulatory Authority website/s (if applicable for the Client) for potential Adverse Drug Reactions (ADRs) and safety information regarding Client's medicinal products and those of the same class- Provide English summary/translation of the detected literature articles (for all suspected ADRs and potentially relevant safety information)- Provide Local Literature Screening tracker monthly to the Project Manager**LCPQA responsibilities (if applicable)**To handle local tasks such as:- Quality complaints (received from HA, distributor, customer)- Deviations (received from HA, distributor, customer)- Quality alerts (received from HA)- Suspected falsified products- Other quality-related requirements received from the local market (HA, media, distributors, wholesalers, pharmacists, health-care professionals, customers).Qualifications**Qualifications and Experience**- Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience- Demonstrated experience within pharmaceutical or CRO industry or Regulatory body- Demonstrated experience within LCPPV/LCPRA roles- PV training and/or working experience and other educational or professional background as required locally- Expert knowledge of ICH GVP and most relevant legislation/ local requirements for territories of competency- Knowledge of ICH GCP preferable- Proficiency in English, both written and verbal and in local language(s- **Special skills**- Strong planning, strategizing, managing, monitoring, scheduling, problem-solving and critiquing skills- Exceptional written and verbal communication skills to clearly and concisely present information- Outstanding interpersonal skills in a fast-paced, deadline oriented, and changing environment- Remarkable attention to detail- Ability to exercise sound judgment and make decisions independentlyAdditional InformationAll your information will be kept confidential according to EEO guidelines.**Our Offer**:- Work within a successful, highly qualified and dynamic team- Professional training and career development in a fast-growing healthcare company
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Local Contact Person for Pharmacovigilance
hace 2 semanas
Madrid, Madrid, España PVpharm A tiempo completoPVpharm is searching for Local Contact Persons for Pharmacovigilance in several countries.Job descriptionAs a Local Contact Person for Pharmacovigilance you will be involved with different projects, and will provide your expertise within different areas of Pharmacovigilance.Your activities will be mainly: Act as a Local Contact Person for Pharmacovigilance...
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Local Contact Person for Pharmacovigilance
hace 2 semanas
Madrid, España PVpharm A tiempo completoPVpharm is searching for Local Contact Persons for Pharmacovigilance in several countries. **Job description** As a Local Contact Person for Pharmacovigilance you will be involved with different projects, and will provide your expertise within different areas of Pharmacovigilance. Your activities will be mainly: - Act as a Local Contact Person for...
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Madrid, Madrid, España IQVIA A tiempo completoLocal Contact for Pharmacovigilance with Estonian and English languageAs the Local Contact for Pharmacovigilance, you will act as local contact for Pharmacovigilance for customers requiring the services for their product(s). This role can be conducted either Home Based / Hybrid / Office based from anywhere in Europe - the choice is yours.RESPONSIBILITIES...
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Freelance Local Contact Person for
hace 3 semanas
Madrid, España PrimeVigilance A tiempo completoCompany 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...
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Freelance Local Contact Person for
hace 2 semanas
Madrid, Madrid, España PrimeVigilance A tiempo completoCompany DescriptionWe 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 and...
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Pharmacovigilance Lead, Spain
hace 6 días
Madrid, España Merck Gruppe - Msd Sharp & Dohme A tiempo completo.Job DescriptionAre you a passionate pharmacovigilance professional looking for a leadership role in adverse event management? We are seeking a highly skilled and experienced individual to join our team as a Pharmacovigilance Lead. In this role, you will be responsible for ensuring compliance with local laws and regulations, managing adverse event reporting,...
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Pharmacovigilance Lead, Spain
hace 2 semanas
Madrid, España MSD A tiempo completoAre you a passionate pharmacovigilance professional looking for a leadership role in adverse event management? We are seeking a highly skilled and experienced individual to join our team as a Pharmacovigilance Lead. In this role, you will be responsible for ensuring compliance with local laws and regulations, managing adverse event reporting, and serving as...
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Pharmacovigilance Lead, Spain
hace 2 días
Madrid, España Merck Gruppe - Msd Sharp & Dohme A tiempo completoJob DescriptionAre you a passionate pharmacovigilance professional looking for a leadership role in adverse event management? We are seeking a highly skilled and experienced individual to join our team as a Pharmacovigilance Lead. In this role, you will be responsible for ensuring compliance with local laws and regulations, managing adverse event reporting,...
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Pharmacovigilance Lead, Spain
hace 1 semana
Madrid, Madrid, España MSD A tiempo completoJob DescriptionAre you a passionate pharmacovigilance professional looking for a leadership role in adverse event management? We are seeking a highly skilled and experienced individual to join our team as a Pharmacovigilance Lead. In this role, you will be responsible for ensuring compliance with local laws and regulations, managing adverse event reporting,...
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Senior Pharmacovigilance Specialist
hace 1 mes
Madrid, España Pvpharm A tiempo completoDo you want to step up in your career in Pharmacovigilance? PVpharm is searching for an experienced Pharmacovigilance Specialist to provide her/his expertise in our challenging pharmacovigilance projects. You will work with complex projects in collaboration with a multidisciplinary, highly motivated and international team. As a Senior Pharmacovigilance...
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Pharmacovigilance Lead, Spain
hace 1 semana
Madrid, España MSD A tiempo completoJob DescriptionAre you a passionate pharmacovigilance professional looking for a leadership role in adverse event management? We are seeking a highly skilled and experienced individual to join our team as a Pharmacovigilance Lead. In this role, you will be responsible for ensuring compliance with local laws and regulations, managing adverse event reporting,...
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Pharmacovigilance Associate
hace 1 mes
Madrid, España BAXTER A tiempo completo**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
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Pharmacovigilance Manager – Spain
hace 2 semanas
Madrid, Madrid, España resourcing life-science A tiempo completoCompany DescriptionOur client is currently seeking a Pharmacovigilance Manager in SpainJob OverviewResponsible for designing, implementing, and managing pharmacovigilance strategies and activities.Ensure the safety and compliance of pharmaceutical products.Collaborate with cross-functional teams, regulatory authorities, and external partners to maintain a...
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Senior Pharmacovigilance Specialist
hace 2 semanas
Madrid, España Pvpharm A tiempo completoDo you want to step up in your career in Pharmacovigilance? PVpharm is searching for an experienced Pharmacovigilance Specialist to provide her/his expertise in our challenging pharmacovigilance projects. You will work with complex projects in collaboration with a multidisciplinary, highly motivated and international team.As a Senior Pharmacovigilance...
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Senior Pharmacovigilance Specialist
hace 2 semanas
Madrid, Madrid, España PVpharm A tiempo completoDo you want to step up in your career in Pharmacovigilance? PVpharm is searching for an experienced Pharmacovigilance Specialist to provide her/his expertise in our challenging pharmacovigilance projects. You will work with complex projects in collaboration with a multidisciplinary, highly motivated and international team.As a Senior Pharmacovigilance...
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Pharmacovigilance Associate
hace 2 semanas
Madrid, Madrid, España BAXTER A tiempo completoThis is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...
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Pharmacovigilance Physician
hace 2 semanas
Madrid, Madrid, España MRL Consulting Group A tiempo completoPharmacovigilance Physician, Remote Based, SpainA specialist, innovative Pharmaceutical company is expanding their Pharmacovigilance department and seeking to hire an experienced Pharmacovigilance Physician.Responsibilities (include but are not limited to) All aspects of Medical Safety related to developmental and marketed products Medical Review of ICSR's...
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Internship Pharmacovigilance
hace 4 semanas
Madrid, España Johnson & Johnson A tiempo completoJohnson & Johnson is currently seeking a pharmacovigilance intern to join our pharmacology department located in Madrid. **What you will do**: - Translation of source documents in local language. - Reconciliation activities. - Literature search and other related activities. - Local archive management, ensuring documents generated in the daily...
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Qualified Person Responsible for Pharmacovigilance
hace 2 semanas
Madrid, Madrid, España PrimeVigilance A tiempo completoCompany DescriptionWe are PrimeVigilance (part of Ergomed PLC), 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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Internship Pharmacovigilance
hace 1 mes
Madrid, Madrid, España J&J Family of Companies A tiempo completoInternship Pharmacovigilance WDescriptionJohnson & Johnson is currently seeking a pharmacovigilance intern to join our pharmacology department located in Madrid.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments...
