Drug Safety Associate Director
hace 1 día
Drug Safety Associate Director – PharmacovigilanceAn amazing opportunity has arisen for a Drug Safety Associate Director within International Pharmacovigilance (IPV). This position plays a critical role in overseeing local PV processes and day‑to‑day adverse event case management across ex‑US markets, ensuring adherence to applicable regulations, company policies, and procedures.Reporting to the Director PV Lead, the Drug Safety Associate Director may serve as the designated back‑up for the local PV Contact/Local Responsible PV person, managing local PV activities in the PV Lead’s absence and representing PV in cross‑functional and external forums.What You Will DoOversee and execute local PV processes and activities, aligning with local legislation and company procedures; manage local PV agreements, due diligence, PSMP implementation, aggregate report scheduling, training, and safety communications.Support audits and inspections (readiness, conduct, CAPA development) and participate in issue management/compliance activities, including local corrective actions and PV self‑inspections.Maintain and develop local PV procedures and controlled documents (e.g., SOPs, training materials).Ensure implementation and oversight of Risk Minimization Measures and local RMP activities.Monitor Health Authority websites for safety issues, alerts, and new/revised PV requirements; liaise with local business units to provide PV input on strategic decisions; represent PV in cross‑functional forums.Serve as back‑up to the PV Lead when designated, acting as local SME, point of contact for Health Authorities, fulfilling procedural tasks, escalating safety/security issues, and contributing to PV‑impacting strategic decisions.Represent PV in cross‑functional and external forums, supporting strategic decisions and local initiatives.What Skills You Will NeedA degree in health, life sciences, or medical sciences, or equivalent education/experience.At least 4 years’ experience in the pharmaceutical industry; experience supervising people/teams/contractors is preferred if managing staff.In‑depth knowledge of adverse event reporting requirements, PV regulations, PV quality systems, and expert‑level PV process knowledge.Proven experience with PV audits and/or Health Authority inspections.Fluency in English (written and spoken) and proficiency in the local language.Open to travel (0–5%).Exceptional interpersonal communication, organization, presentation, negotiation, and influencing skills.Strong cross‑functional collaboration capability and the ability to work independently, manage multiple priorities and lead change.Demonstrated ability to drive process improvements that enhance quality and add business value; strong strategic thinking.Advanced project management skills, including prioritization and coordination across multiple initiatives.Why Join Us?We keep the patient at the very heart of our work and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.Travel and Work ArrangementsTravel: 0–5%. Shift: Flexible. Work arrangement: Hybrid.#J-18808-Ljbffr
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Drug Safety Associate Director
hace 1 día
madrid, España MSD España A tiempo completoDrug Safety Associate Director – Pharmacovigilance An amazing opportunity has arisen for a Drug Safety Associate Director within International Pharmacovigilance (IPV). This position plays a critical role in overseeing local PV processes and day‑to‑day adverse event case management across ex‑US markets, ensuring adherence to applicable regulations,...
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Drug Safety Associate Director
hace 3 días
Madrid, España Merck A tiempo completoJob DescriptionAn amazing opportunity has arisen for a Drug Safety Associate Director , Pharmacovigilance (PV) within International Pharmacovigilance (IPV). This position plays a critical role in overseeing local PV processes and day‑to‑day adverse event case management across ex‑US markets, ensuring adherence to applicable regulations, company...
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madrid, España Merck A tiempo completoA leading global healthcare company in Spain is seeking a Drug Safety Associate Director in Pharmacovigilance to oversee local processes and manage adverse event case management. This critical role involves ensuring compliance with regulations and company policies while supporting strategic decisions. The ideal candidate will possess a relevant degree and at...
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Drug Safety Associate Director
hace 4 días
madrid, España Merck A tiempo completoJob Description An amazing opportunity has arisen for a Drug Safety Associate Director , Pharmacovigilance (PV) within International Pharmacovigilance (IPV). This position plays a critical role in overseeing local PV processes and day‑to‑day adverse event case management across ex‑US markets, ensuring adherence to applicable regulations, company...
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Drug Safety Associate Director
hace 3 días
Madrid, España Merck Gruppe - MSD Sharp & Dohme A tiempo completoOverview Job DescriptionAn amazing opportunity has arisen for a Drug Safety Associate Director , Pharmacovigilance (PV) within International Pharmacovigilance (IPV). This position plays a critical role in overseeing local PV processes and day-to-day adverse event case management across ex-US markets, ensuring adherence to applicable regulations, company...
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Drug Safety Associate Director
hace 1 día
Madrid, España Merck Gruppe - MSD Sharp & Dohme A tiempo completoOverview Job Description An amazing opportunity has arisen for a Drug Safety Associate Director , Pharmacovigilance (PV) within International Pharmacovigilance (IPV). This position plays a critical role in overseeing local PV processes and day-to-day adverse event case management across ex-US markets, ensuring adherence to applicable regulations, company...
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Drug Safety Associate Director
hace 3 días
madrid, España Merck Gruppe - MSD Sharp & Dohme A tiempo completoOverview Job Description An amazing opportunity has arisen for a Drug Safety Associate Director , Pharmacovigilance (PV) within International Pharmacovigilance (IPV). This position plays a critical role in overseeing local PV processes and day-to-day adverse event case management across ex-US markets, ensuring adherence to applicable regulations, company...
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Drug Safety Associate Director
hace 4 días
madrid, España Merck Gruppe - MSD Sharp & Dohme A tiempo completoA leading pharmaceutical company based in Madrid is seeking a Drug Safety Associate Director to oversee pharmacovigilance processes across ex-US markets. The role entails managing local PV activities, supporting audits, and maintaining documentation while ensuring compliance with regulations. The ideal candidate has a degree in life sciences and at least 4...
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Drug Safety Associate Director
hace 3 días
Madrid, España Merck Gruppe - MSD Sharp & Dohme A tiempo completoA leading pharmaceutical company based in Madrid is seeking a Drug Safety Associate Director to oversee pharmacovigilance processes across ex-US markets. The role entails managing local PV activities, supporting audits, and maintaining documentation while ensuring compliance with regulations. The ideal candidate has a degree in life sciences and at least 4...
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Drug Safety Associate Director
hace 4 días
Madrid, España MSD A tiempo completoJob Description An amazing opportunity has arisen for a Drug Safety Associate Director , Pharmacovigilance (PV) within International Pharmacovigilance (IPV). This position plays a critical role in overseeing local PV processes and day-to-day adverse event case management across ex-US markets, ensuring adherence to applicable regulations, company policies,...
