Pharmacovigilance

Pharmacovigilance

The FDA recalled more than 14,000 drugs in the US in the last 10 years, which averages out to approximately four recalls a day. This statistic highlights the importance of ongoing drug safety, also known as Pharmacovigilance. The ongoing tracking of adverse effects after new drugs have been approved by regulatory agencies is one of the key challenges of modern medicine. Given the importance of this work, life sciences companies need qualified and capable clinical professionals to ensure the safety and effectiveness of their drugs.

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 of around $10.6bn by 2026, according to Acumen Research. Let EPM Scientific find and deliver top Pharmacovigilance talent when you need it.

How we can help

EPM Scientific has been the preferred talent partner of leading companies and promising start-ups for more than a decade. We invest in premium technologies for service of consistent quality and in the ongoing development of our talent specialists so that they can stay ahead of the latest hiring trends. With us, you gain a talent partner that offers ongoing support as your company surges forward to realize its objectives.

Pharmacovigilance talent solutions

Whether your company is looking for contract, permanent, or multi-hire pharmacovigilance talent solutions, EPM Scientific will ensure that its needs are met quickly and efficiently. Drawing on our global network of talent hubs, we will find qualified and experienced individuals who have proven their worth when it comes to monitoring, reporting, and assessing the safety of new drugs. Get the talent your company needs, from contract workers to interim managers, for time-sensitive and long-term hires. Additionally, our team of talent experts offers bespoke retained and contingent services. As part of Phaidon International, we focus on sourcing talent, offering value-added services, and top-level account management.

Don’t just take our word for it

“EPM Scientific has been a great partner working with Christy Sterbenz and I to help support recruitment for Global Patient Safety at Amgen. They have been able to quickly pick up on the needs of the organization and the ideal phenotype for our Global Safety Officer & Global Safety Physician positions. We truly value their partnership. EPM Scientific displays valuable leadership skills, taking initiative to ensure that candidates are sufficiently prepared for interviews.

EPM Scientific also provides very thorough details on candidates that are shared to us, making sure we have a good understanding of their background, career aspirations, and logistical matters such as compensation, relocation, immigration, and other key topics. They are very quick to respond and stay on top of things very carefully, ensuring nothing slips through the cracks. They are also very pleasant to work with and always have a very positive attitude, even when we don’t move forward with candidates. Overall, I’d be happy to recommend EPM Scientific.”Tim Merritt, Talent Advisor, Amgen


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Benefits of working with us

Experience

We have over a decade’s worth of experience as a leading talent partner in Life Sciences & Pharma.

Network

A vast, global network of the best, in-demand professionals, working with the world’s largest Life Sciences institutions, to take drugs, devices and therapeutic applications through from conception to completion.

Knowledge

Our award-winning talent specialists offer bespoke, tailored guidance on the latest hiring trends and industry news to help you achieve your goals.

Looking to hire?

Pharmacovigilance Jobs

At EPM Scientific, we pride ourselves on sourcing the best talent for an array of Pharmacovigilance and drug safety roles at industry leading and startup life sciences companies. Some of the roles we deliver talent for include Drug Safety Scientist, Clinical Drug Safety Officer, Drug Safety Medical Writer, Aggregate Report Writer, Team Lead, Team Manager, Associate Director, Director, and Vice-President of Pharmacovigilance.

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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