Pharmacovigilance

Pharmacovigilance

By the time medicinal products are granted a marketing authorisation, knowledge about their safety is incomplete because the clinical trials investigating the safety profile and efficacy are usually performed with a relatively small number of subjects. The total number of adverse-event reportstotalled 60,000 across Europe, according to a report from theEuropean Medicines Agency. This figure highlights one of the key issues facing modern medicine, the need to track adverse events long after regulatory agencies have approved new drugs - enter pharmacovigilance. Typically, patients who want to report an adverse event are directed to their doctor, who can then relay that information to a pharmacovigilance data system. However, sinceonly five percent of doctorsare estimated to participate in any pharmacovigilance system, this process can be inefficient at cataloguing patient issues.

TheGerman Medicines Actprovides information obtained during the use of a medicinal product by after the marketing authorisation is granted. This is done for all finished products on the market in Germany and is the most important duty of the Pharmacovigilance Division. This Division continuously informs about the adverse drug reactions and interactions related to the use of medicinal products which have become known and ensures that patients, medical doctors and other interested parties are made aware of existing risks as well as of possibilities to decrease them. Education is the key to progress in the area of pharmacovigilance. According to a2018 report by the World Health Organization, more than 50% of all medicines are prescribed, dispensed or sold inappropriately, and 50% of patients fail to take them correctly.

A bright future is assured for employees within the sector as the global pharmacovigilance market size is estimated to grow at a CAGR of above 12.8 % over the forecast time frame 2019-2026 and reach the market value around €9.5bn by 2026, according toAcumen Research.

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. Our expert consultants place talent in the safety/pharmacovigilance industry in Germany and across Europe.


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Safety/Pharmacovigilance Jobs

Pharmacovigilance Safety Scientist

Title: Pharmacovigilance Scientist A small rapidly-growing bio-pharmaceutical company is seeking an experienced pharmacovigilance scientist to grow their pharmacovigilance team. You will play a key role in accelerating the development of a new-class of drugs to help those suffering with autoimmune diseases. Responsibilities: Maintain and review aggregate reports. Manage and perform signal detection activities. Review and escalate AE/ SAE's. Manage vendors and ensure timely reporting. Review and contribute to SOP's, SMP's and SDEA's. Requirements: Bachelor's degree in health or science related field. 3+ years of experience in the Pharmacovigilance space with project management experience. Knowledge of international regulatory submission guidelines Experience working with safety databases Experience with MedDRA coding

US$140000 - US$140001 per year
California
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Medical Safety Physician

Title: Experienced Medical Safety Physician with Leadership Skills needed in Seattle, WA Introductory Paragraph: Do you have a passion for pharmacovigilance and pharmaceuticals? Are you an experienced physician with a proven track record in leadership? If you answered yes to these questions, then we have the perfect opportunity for you. Our client, a growing mid size pharmaceutical company, is seeking a talented Medical Safety Physician to join their team in beautiful Seattle. Qualifications: To be considered for this position, you must have the following qualifications: - MD or DO degree from an accredited institution - 5 years of practicing medicine as a licensed physician - At least 3 years experience working within the pharma industry. Skills: As the Medical Safety Physician, you will be responsible for ensuring that all safety information is collected during clinical trials and post-marketing phase while maintaining compliance with relevant regulations. You will also be required to lead teams on projects across different stages of the drug development life cycle including R&D, Clinical Development, and more. Therefore, strong communication skills along with the ability to lead are critical success factors. In addition, your role will involve review, creation, modification, and updating of risk documents such as SOPs. Your expertise in risk management plans (RMP) will be highly valued in this role. Responsibilities: As part of your role, you will be responsible for the following: - Leading cross-functional teams to ensure that the safety profile of the company's products is well-characterized and communicated to stakeholders. - Providing medical and scientific oversight of safety-related activities across different stages of the drug development life cycle. - Developing and implementing risk management strategies to minimize potential risks associated with the company's products. - Ensuring that all safety information is collected, analyzed, and reported in compliance with regulatory requirements. - Collaborating with colleagues in other departments such as Clinical Development, Regulatory Affairs, and Medical Affairs to ensure that safety-related issues are identified and addressed in a timely and effective manner.

Negotiable
Seattle
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Senior Manager of PV Operations Passionate about Drug Delivery

Title: Senior Manager PV Operations Salary: $70-120/hr We are partnering with a global pharmaceutical company that works on getting cardiology, oncology, women's health, and dermatology products on the market. As the Senior Manager PV Operations consultant, you will take charge in reviewing study documents, communicating with PV vendors, and working on quality compliance practices for the company's product portfolio. If you have an affinity for the mentioned therapeutic areas, enjoy looking over safety documents, and working with vendors, this may be the job for you! The Senior Manager PV Operations will be responsible for: Participating actively in Study Management Teams (SMTs) as a representative of the PV Operations team Monitoring PV vendors to account for ICSRs, SOPs, and aggregate reports (SUSAR, PSUR, PADER, DSUR, IND) Overseeing creation of programs and Service Provider vendors to ensure rollout of MAPs and vendor partnership The Senior Manager PV Operations should have the following qualifications: Bachelor's in health care field with at least 5 years of experience in drug safety Mastery of FDA regulations, ICH guidelines, and other regulatory documents CAPA deviation and CCDS work Can travel up to 20% for the job domestically and internationally Benefits Medical, dental, and vision insurance 401K If you are interested in the Senior Manager PV Operations role, apply today!

US$70 - US$120 per hour
United States of America
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Senior Director Pharmacovigilance and Drug Safety

Title: Senior Director Pharmacovigilance and Drug Safety Introduction: A leading pharmaceutical company based in New Jersey is seeking a highly skilled and experienced Senior Director of Pharmacovigilance and Drug Safety. This permanent position offers an exciting opportunity for the right candidate to lead end-to-end case processing while managing vendors & call centers. The successful applicant will be responsible for overseeing aggregate reports as well as signal detection. Responsibilities: As our new Senior Director of Pharmacovigilance and Drug Safety, you will be responsible for a wide range of tasks including but not limited to: - Overseeing End-To-End Case Processing You will be responsible for managing all aspects related to adverse event reporting including medical review processes. This will involve working closely with cross-functional teams such as clinical development, regulatory affairs, and medical affairs to ensure timely and accurate reporting of safety data. - Signal Detection You need previous expertise detecting signals from various data sources by using statistical methods. You will be responsible for overseeing signal detection activities and working closely with cross-functional teams to assess the clinical relevance of signals and determine appropriate risk management strategies. - Aggregate Reports You will be responsible for overseeing the preparation and submission of aggregate reports such as periodic safety update reports (PSURs) and development safety update reports (DSURs). This will involve working closely with cross-functional teams to ensure the accuracy and completeness of safety data. - Risk Management You must have experience creating risk management strategies that meet regulatory requirements such as REMS programs or other safety monitoring procedures. In addition, you will be responsible for identifying potential safety risks and developing appropriate risk mitigation strategies. - Vendor And Call Center Management In this role, you'll take charge of vendor selection & oversight which means ensuring compliance with global regulatory authorities. You will be responsible for managing relationships with external service providers such as contract research organizations (CROs), call centers, and safety database vendors. Qualifications/Skills Required: To be considered for this role, you must meet the following qualifications: - MD Or Pharmd Needed For Role - Relevant Experience As A Pharmacivgilence Director Experience working within the Pharmaceuticals sector would be advantageous. You should have a minimum of 10 years of experience in pharmacovigilance, with at least 5 years in a senior leadership role. - Strong Leadership Skills You should have a proven track record of leading and managing cross-functional teams and external service providers. - Excellent Communication Skills You should have excellent communication skills, both verbal and written, and be able to communicate complex safety information to a wide range of stakeholders.

Negotiable
New Jersey
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Senior Manager, Pharmacovigilance Operations

Sr. Manager- Pharmacovigilance Operations Salary: 160,000 Remote A rapidly growing midsize bio-pharmaceutical company is looking for a Sr. Pharmacovigilance Operations Manager to provide leadership to the pharmacovigilance team regarding the management of case processes, vendors, periodic safety reports, and safety databases. This position will support risk management and PV activities on both clinical trials and post marketed products. Responsibilities: Vendor oversight and management. Coordinate and review ICSR activities and review AE's Track and report KPI's Author and review SMP's, safety data exchange agreements, and SOP's. Assist with the preparation of DSUR's, CSRs, RMP, and IBs. Manage CAPA activities. Oversee quality control of SAE and ICSR cases in safety databases. Requirements: Bachelors/Advanced degree in life science or other healthcare related professions (MD, RN, PharmD, PhD, etc.) 6-8 years in the PV space. Experience in PV activities on both pre- and post-approved products. Experience in using ARGUS. Working understanding of MedDRA and WHO

US$160000 - US$160001 per year
United States of America
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