Cenca - Ra & Pv Sr Specialist

Job DescriptionOrganon is a Women's Health Company that believes in a better and healthier every day for every woman We are a passionate, global community of thousands dedicated to redefining the future of women's health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It's going to be an exciting future—come be a part of it Main Responsibilities: Responsible for all Pharmacovigilance and Regulatory Affairs submission requirements and Pharmacovigilance activities for their assigned product portfolio according to Organon policies and procedures in Central America and Caribbean countries, as applicable.The Senior Specialist is the regulatory contact with local stakeholders and headquarters and is the direct contact for health authority submission specific topics.The Senior Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight. CompetenciesKnowledge: Central America & Caribbean countries legal regulationsRegulatory and Pharmacovigilance activitiesLeadership behaviorsLanguages: SpanishEnglish (Reading, writing and speaking) -advanced levelSkills (professional and/or technical)Proficient in MS Office softwareAttention to detailAbility to work cross-functionally in pharmaceutical company environmentTime management, Good self-organization, creativity and initiative.Flexible, Team-player, AccurateEffective communication skills (both written and oral).Ability to transmit knowledge to othersExperience4 to 8 years in Regulatory Affairs at Pharmaceutical IndustryGood knowledge of ICH, GMP and local regulations.+3 years in similar positions.Education / CertificatesPharmacist or related sciences