Pharmacovigilance

Pharmacovigilance

EPM Scientific:

Specialist Talent Partner in Pharmacovigilance (Drug & Product Safety) Recruitment

​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

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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.

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Looking to hire?

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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 QA

Seeking an experienced PV QA Consultant to enhance compliance within a global PV system. This role involves leading PV audits, managing compliance across affiliates, and supporting interactions with regulatory authorities. Key Responsibilities: Oversee global PV audit program, ensuring adherence to FDA, EMA, and international PV regulations. Implement and standardize PV systems across affiliates, driving quality and compliance. Support regulatory inspections and manage CAPAs for PV activities. Requirements: Master's in Pharmacy, Life Sciences, or related field. 10+ years in PV QA, with audit and inspection experience. Expert knowledge of global PV regulations; fluent in English (German/French a plus) For further information about this position, please apply with your CV *Please note, only those with the right to work in Switzerland can apply!

Negotiable
Basel
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Sr Manager Drug Safety Operations

Job summary: This role is responsible for assisting in the oversight of all operational activities related to drug safety studies, from start-up to closeout. It involves monitoring clinical trial safety vendor activities and supporting key tasks related to case processing management within the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations, as well as the procedures of the Global Patient Safety (GPS) department. RESPONSIBILITIES: Technical Responsibilities include but are not limited to: Process and evaluate Serious Adverse Events (SAEs) and Adverse Events (AEs) from the time of receipt until case closure in the Argus database, including generating queries, MedDRA coding, and narrative writing. Manage and implement a high standard of case quality review to ensure accurate medical safety data documentation with the support of the Drug Safety Physician. Perform Safety Study Lead tasks, such as reviewing Investigator Brochures and study protocols, and contributing to IND Annual Reports in collaboration with the Drug Safety Physician. Develop study-specific and program-level safety management plans using templates from CRO. Create, review, and update drug safety forms and templates to align with relevant clinical operation documents (e.g., SAE data collection forms and CRFs). Monitor the activities of CROs and partners to ensure compliance with applicable Safety Management Plans (SMPs), Pharmacovigilance Agreements (PVAs), and other contractual obligations. Collaborate with Data Management to carry out SAE reconciliation activities per study-specific plans. Train new safety staff on the Argus system and case processing. Work with other departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure proper collection and management of safety data. Lead cross-functional projects, gather input, and achieve consensus on safety operational topics. Develop and/or update Standard Operating Procedures (SOPs), processes, and practices for study lead and SAE case processing activities, in compliance with drug safety and pharmacovigilance regulations and standards. Manage and execute personal work effectively to achieve departmental goals. Additional duties and responsibilities as assigned. EDUCATION & EXPERIENCE: Education/Experience: BS/BA degree in a related field with a minimum of 9 years of relevant experience; or MS/MA degree in a related field with at least 7 years of relevant experience; or Experience/understanding of study management Experience/The Ideal Candidate: BS or MS in Nursing, Pharmacy, or a related clinical degree with at least eight years of clinical experience. Experience in the biotech/pharmaceutical industry and/or oncology is preferred. Familiarity with the Argus safety database is preferred. Experience in processing clinical trial and spontaneous adverse events.

Negotiable
San Francisco
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Medical Safety Clinician

Utilizes clinical experience and training in patient care to lead or participate in safety signal detection activities aimed at identifying, evaluating, validating, and managing signals for marketed products. This includes conducting individual and aggregate data analyses, interpreting safety signals and trends, and documenting and communicating safety risks in collaboration with key internal and external stakeholders. Draws on previous clinical experience to assess the risks and benefits of medical devices concerning patient safety. May act as a medical reviewer for clinical trials and provide clinical insights to support life-cycle management activities. ESSENTIAL DUTIES Conducts professional medical evaluations of medical device performance, analyzing clinical data from complaints, and assessing the impact on the safety of the company products. Performs searches and reviews of adverse event data, literature, and other relevant safety data for signal surveillance and detection. Collects and summarizes vigilance data for integration into Quality's Post Market-Surveillance Reports. Reviews and contributes to risk and benefit-risk assessments for marketed products, including assessments related to hazardous materials for compliance; oversees safety evaluations impacting patient and donor safety; and prepares risk management plans and reports. Reviews and assists with post-marketing aggregate safety reports (PSURs, PADERs, SUSARs, PBRERs, DSURs, IND annual reports) to ensure consistent communication on safety topics across various regulatory documents; reviews safety sections of the Summary of Safety and Clinical Performance (SSCP) and clinical study documents. Assists in the development of clinical study documents, including informed consent forms and clinical study reports; supports safety-related activities for pre-market applications and regulatory submissions. May contribute to clinical development plans to ensure appropriate medical safety oversight and post-market clinical follow-up (PMCF) studies. Collaborates with cross-functional teams on risk minimization strategies and may provide clinical insights during product development. Participates in relevant Health Hazard Evaluations and field action/recall activities. Engages with Clinical and Scientific Affairs to support product life-cycle management goals. OTHER DUTIES AND RESPONSIBILITIES The GMS Clinician may also perform or assist with medical monitoring functions for clinical studies, including: Reviewing adverse events (AEs) and serious adverse events (SAEs) to assess device and study relatedness and expectedness. Providing input on clinical development plans, protocol design, and risk assessments. Assisting in clinical data management, including MedDRA and WHO DD coding. Reviewing study deliverables such as final narratives and clinical study reports. Analyzing safety and efficacy trends across various clinical trials. Acting as the medical monitor contact for investigators and study sites regarding protocol compliance and participant safety. MINIMUM QUALIFICATION REQUIREMENTS Education A degree appropriate for a licensed healthcare professional (e.g., BSN/RN, MSN/RN, Nurse Practitioner) or equivalent education and experience sufficient to perform essential job functions. An advanced degree in Epidemiology, Biostatistics, Health Surveillance, Patient Safety, or Medical Quality is preferred. Experience Minimum of 3 years of clinical/hospital experience after postgraduate training. Preferred: Two years in a medical safety role within the pharmaceutical, biotech, or medical device sectors, with experience in transfusion medicine, blood banking, cellular therapy, and/or apheresis. Skills Comprehensive knowledge of global regulations and reporting requirements related to medical device and pharmacovigilance, including signal detection and risk management activities. Understanding of drug/device development and lifecycle management processes. Familiarity with therapeutic areas related to the company products. Strong clinical and scientific judgment. Ability to apply medical terminology and concepts in various contexts. Proficient in analyzing datasets, interpreting results, and clearly communicating complex scientific information to diverse audiences. Capable of gathering data from multiple sources, creating case narratives, and conducting risk assessments. Effective teamwork and self-direction, with the ability to work independently. Proficient in relevant PC software applications.

Negotiable
Denver
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