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.

Global Safety Officer / Medical Director Drug Safety

I am partnered with a pioneering, global biopharma who has led the industry in remarkable scientific breakthroughs to enhance people's lives. They are currently looking for a Medical Director, Drug Safety to add to their Immunology group. Internal & External Safety Expert Provide pharmacovigilance (PV) and risk management expertise to both internal and external stakeholders. Act as the safety expert for products. Stay informed about the product, its environment, and recent literature. Maintain PV expertise and a thorough understanding of international safety regulations and guidelines. Lead cross-functional Safety Management Teams (SMTs). Communicate and represent PV analyses and positions within project/product teams, safety governance, and benefit-risk governance activities and committees (e.g., Safety Management Committee, Benefit-Risk Assessment Committee), with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations. Offer strategic and proactive safety input into development plans. Support due diligence activities and pharmacovigilance agreements. Signal Detection & Assessment Responsible for signal detection and analysis. Collaborate with the Center of Excellence for Signal Detection, Data Mining, and Safety Epidemiology group. Identify and implement proactive safety analysis strategies to further define the safety profile. Lead aggregate safety data review activities and coordinate safety surveillance activities. Risk Assessment & Risk Management & Benefit-Risk Assessment Provide proactive risk assessment. Co-lead benefit-risk assessment with other relevant functions. Develop risk management strategies and plans and monitor their effectiveness. Collaborate with the Center of Excellence for Risk Management and Epidemiology/Benefit-Risk groups. Submission Activities Represent the safety position in cross-functional submission teams. Ensure the generation, consistency, and quality of safety sections in submission documents. Write responses or contributions to health authorities questions. Support the preparation and conduct of Advisory Committee meetings. Report Writing Document, contribute to, coordinate, review, and/or validate periodic reports, such as RMP updates, IND Annual Reports, Annual Safety Reports/Development Safety Update Reports, and Periodic Safety Update Reports. Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products.

US$240000 - US$270000 per year
Boston
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Freelance Validation / LIMS

We are looking to speak with freelance software validation experts in Germany for a fully remote 2-year project - you will play a crucial part in the digitalization efforts of a major pharma company, ensuring that their software systems meet the highest standards of quality and compliance. You will be working specifically on Quality Control Laboratory Information Management Systems (LIMS).

Negotiable
Deutschlandsberg
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AD/Director PV Operations

The individual will oversee the daily operations of the Pharmacovigilance function, ensuring adherence to standard operating procedures, policies, industry best practices, and relevant regulations. Primary Responsibilities: Oversee the daily management and execution of pharmacovigilance (PV) operations. Ensure compliance with regulatory requirements, PV agreements, and internal SOPs. Act as a representative for the Drug Safety and Pharmacovigilance departments on clinical development teams. Supervise the processing of Serious Adverse Events (SAEs) by outsourced vendors and monitor compliance operations. Develop and implement strategies to maintain high-quality standards by analyzing and mitigating compliance risks. Manage SAEs, including case triage, data entry, coding review, and narrative writing. Provide support for safety operations in external submissions, signal detection, and risk management planning. Assist in the preparation of periodic safety reports (e.g., DSUR, PSUR). Ensure the compliant exchange of safety data between the company and its partners. Collaborate with the quality management system in Drug Safety to ensure department standards are met, including training, performance monitoring, continuous improvement actions, and good documentation practices. Work with the QA department to maintain high PV inspection readiness across all regions/countries. Collaborate with contract service providers for case processing, aggregate reporting, and quality management activities. Manage the performance of PV systems. Support root cause analysis of deviations relevant to PV systems. Participate in regulatory inspections and company audits, including FDA/MHRA/EMA PV inspections. Prepare responses to audit findings related to the PV department. Manage reconciliation activities with other departments and vendors. Provide project management support for NDA/MAA submission activities and prepare safety data submissions. Support cross-functional teams in patient narrative efforts. Provide strategic oversight of vendors. Manage the quality and compliance of assignments, including training and mentoring.

US$170000 - US$230000 per year
Utah
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Director PV/Quality Management Systems

I am recruiting for a Director, PV QMS (Quality Management System) with a stable biotech who has multiple marketed medicines, a premier late stage pipeline and has been leading their industry for 20+ years. This position involves overseeing all activities related to the Pharmacovigilance Quality Management System, ensuring audit and inspection readiness globally. Key responsibilities include: Leading Compliance & Training within the Safety/PV team and cross-functionally to drive global compliance. Providing strategic input and tactical implementation for Pharmacovigilance activities and projects. Identifying and communicating compliance risks and overseeing action plans to mitigate those risks. Leading and developing operational excellence in corrective and preventative action deliverables to ensure timely compliance.

Negotiable
United States of America
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Director/Sr Director PV Operations

Our client is currently seeking a Director/Senior Director, Pharmacovigilance Operations. This role is responsible for the oversight of the Pharmacovigilance (PV) Operations including oversight of PV safety vendor activities, overseeing interactions between pharmacovigilance and other internal departments, monitoring PV quality/compliance activities, and liaising with external partners for the contractual exchange of safety information. This position requires an experienced and accomplished safety operations professional who can provide functional and technical expertise while collaborating with multiple stakeholders. Job Responsibilities and Duties include, but are not limited to, the following: Oversight of safety vendor activities including the case processing of adverse events in the global safety database for investigational & approved products; reconciliation of adverse event information with partners and other parties, and the production of a variety of safety reports Oversight of submissions of expedited reports to the FDA & other health authorities Develop standard procedures and guidelines for safety operations Participate in the creation of cross-functional Pharmacovigilance procedures Effectively utilize Key Performance Indicators and other metrics to assess compliance, productivity, opportunities for quality improvement, and to measure effectiveness of change initiatives Proactively lead case processing/ case quality improvement initiatives Fully support training of department personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc., in collaboration with the Quality organization Negotiate safety data exchange agreements and processes with business partners Provide support and subject matter expertise during audits and inspections Ensure readiness and management of FDA inspections Represent drug safety on project teams, other departments, and committees as needed

Negotiable
United States of America
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