Job Description
Are you a passionate pharmacovigilance professional looking for a leadership role in adverse event management? We are seeking a highly skilled and experienced individual to join our team as a Pharmacovigilance Lead. In this role, you will be responsible for ensuring compliance with local laws and regulations, managing adverse event reporting, and serving as the primary point of contact for the local Health Authority. This role requires proficiency in Spanish language and residence in Spain.
Key Responsibilities: Lead the strategic planning and implementation of pharmacovigilance objectives in your country, including department structure, processes, and local Health Authority policy implementation.Manage and develop local resources, including recruitment, training, and performance management.Serve as the local Contact Person for Pharmacovigilance (CPPV) and ensure compliance with all local laws and regulations.Oversee daily pharmacovigilance processes and activities, collaborating with internal teams and external parties as necessary.Ensure that adverse experiences and product quality complaints are reported in compliance with corporate policies and procedures.Ensure that all required trainings are completed by the PV team and maintain the local training matrix and onboarding plans.Coordinate the translation of pharmacovigilance documents and ensure quality control checks.Maintain the filing, storage, and archiving of safety-related documentation in accordance with company policies and local requirements.Participate in compliance activities and coordinate the preparation of necessary documents for deviations from internal policies and procedures .Ensure audit / inspection readiness, coordinates, leads, and actively participates in local audits and inspections.Develop and maintains local Pharmacovigilance controlled documents.Identify procedural gaps and implement solutions in collaboration with stakeholders.Responsible for ensuring appropriate implementation and oversight of Additional Risk Minimization Measures locally.Act as a subject matter expert on relevant pharmacovigilance regulations, processes, and procedures.Collaborate with internal stakeholders to ensure compliance with pharmacovigilance requirements for new initiatives and programs.Provide expertise in the planning, execution, and maintenance of major projects.Represent pharmacovigilance in cross-functional forums and serve as a local expert on PV regulations.Participate on local company committees and councils (as appropriate) for matters impacting PV.Requirements: Health, life science, or medical science degree or equivalent.At least 15 years of experience in the pharmaceutical industry with a focus on safety and pharmacovigilance activities.Experience in supervising and managing people.Strong leadership, communication, decision-making, and problem-solving skills.Detailed knowledge of adverse event reporting requirements, PV regulations, and PV quality management systems.Experience with PV audits and/or Health Authority inspections.Fluency in English and proficient in SpanishAbility to travel within the region and globally.Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements:
HybridShift: Valid Driving License: Hazardous Material(s): Job Posting End Date:
07/9/2024*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:07/09/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R300425
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