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 โ‚ฌ9.5bn 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

Senior Director Medical Safety & Pharmacovigilance

Position Summary: The Senior Director of Medical Safety and Pharmacovigilance will lead the medical safety activities for assigned products, ensuring continuous assessment of their safety profiles and benefit-risk balance. This role involves providing strategic leadership in medical safety, supporting clinical development programs, regulatory filings, and global post-marketing safety activities. Key Responsibilities: Oversee the medical assessment and interpretation of safety data from various sources, including clinical trials, post-marketing reports, and literature. Lead safety monitoring and signal detection efforts, ensuring timely identification and communication of safety concerns. Collaborate with cross-functional teams to support clinical studies, including the development and review of clinical trial protocols, informed consent forms, and safety information. Provide medical input for the generation of aggregate safety reports and risk management plans. Develop and maintain standard operating procedures and other guidance documents related to drug safety. Serve as a subject matter expert for vendors providing pharmacovigilance services. Respond to safety-related inquiries from regulatory authorities and participate in regulatory inspections. Mentor and manage the Drug Safety team, fostering a collaborative and high-performance environment. Requirements: Medical degree (MD) with at least 8-10+ years of experience in drug safety and pharmacovigilance within the pharmaceutical industry. Proven expertise in medical safety assessments, safety surveillance, and risk management. Strong knowledge of US and EU pharmacovigilance regulations and guidelines. Excellent leadership, organizational, and communication skills. Ability to work effectively in a fast-paced, cross-functional environment.

Negotiable
United States of America
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Vice President, Drug Safety

Summary The Vice President of Drug Safety will oversee all activities and deliverables of the Drug Safety Department. This includes providing operational and medical oversight for safety activities related to all medicinal products, ensuring compliance with regulatory requirements, and driving risk management strategies throughout the product lifecycle. The role involves supervising and mentoring the Drug Safety team, collaborating with other department heads, and providing quality oversight to safety service providers. Responsibilities: Manage the receipt, processing, review, and reporting of adverse events. Oversee the review and interpretation of aggregate safety data and its impact on clinical programs. Lead the signal management system, including detection, evaluation, and management of safety signals. Serve as the senior safety advisor on project and product teams. Collaborate with regulatory affairs on safety labeling updates. Ensure compliance with SOPs, policies, regulations, and laws. Provide oversight on safety service providers' work. Lead and develop the Drug Safety team, setting performance standards and managing performance. Work closely with the Business Development department on safety data disclosure for partnerships. Requirements: MD degree with 15+ years of experience in drug safety/pharmacovigilance. In-depth knowledge of drug safety practices and regulations. Direct experience with Oncology is a must** Proven leadership capabilites with an open door policy Strong organizational, management, and communication skills. Ability to work effectively in a fast-paced environment and think creatively.

Negotiable
New Jersey
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