Drug Safety Physician

Who we are?

INSUD PHARMA operates across the entire pharmaceutical value chain, delivering specialized expertise and experience in scientific research, development, manufacturing, sales and marketing of a wide range of value-adding active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and branded pharmaceuticals, for human and animal health. INSUD PHARMA believes in innovation and sustainable development. Our commitment is to improve people`s health and quality of life, providing access to quality medicines at affordable prices, and to continuously expand our efforts and R&D investment to develop new and better therapies.

General Responsibility

Provision of medical and scientific support to the pharmacovigilance teams in the different business units of Insud Pharma.

Specific Responsibilities

• Perform medical assessments of adverse event reports and MedDRA adverse event coding.
• Prepare and/or review of aggregated reports, such as Periodic Safety update Reports, Development Safety Update Reports, Addendums to the Clinical Overviews, Risk Management Plans, among others. Provide input to benefit risk-assessments and Clinical Expert Statement as applicable.
• Review documents related to clinical trials and post-authorization safety studies where the R&D departments and companies of Insud Pharma require support.
• Assist with the medical review and narrative writing in completion of clinical study reports and clinical documents supporting a marketing authorization application.
• Give medical support to the manufacturing sites when reassessment of the benefit-risk balance of manufactured products is required.
• Provide answers to medical inquiries and prepare benefit risk assessments reports if needed.
• Provision of a medical expert opinion in the medical monitoring, signal detection and risk management activities.
• Participation in the decision-making performed by the Signal Management Team and Signal Detection Committee.
• Review global scientific literature, social media, and other sources of safety information with the purpose of continuously monitoring the benefit-risk balance of Insud Pharma product portfolio and development candidates.
• Provide 24/7 medical assistance to the Qualified Person of Pharmacovigilance (QPPV).
• Collaborate in the establishment of a Quality Pharmacovigilance System for the Medical Safety and Business Support Department within Insud Pharma Global Pharmacovigilance Department.
• Provide medical safety evaluations for the creation and maintenance of product information documents (e.g. Reference Safety Information/Core datasheets/SmPC).
• Collaborate with other departments and business units of Insud Pharma, affiliates, and business partners.
• Collaborate with external key stakeholders as applicable.

Requirements and personal skills

• Education: Degree in Medicine. A full and partly completed postgraduate program with a curriculum in pharmacovigilance would be advantageous.
• Experience (years/area): Hospital medical experience in patient care (e.g. medical residency of internal medicine, clinical pharmacology, or similar) and preferentially some years of experience in a PV Department of a medium-large pharmaceutical company, a CRO or in a hospital setting managing the system of adverse event reporting.
• Specific Knowledge: Knowledge of pharmacovigilance vocabulary and current European PV Legislation and Good pharmacovigilance practices (GVP).
• Languages: Fluent in Spanish and English. Knowledge of other languages will be an asset.
• Travels: Willing to travel, as required.
• Personal skills: Communication, analytical skills, sense of responsibility, sociable, flexibility.