Pharmacovigilance Operations Manager

Position reputed company: We are seeking a reputed company, proactive, and detail-oriented Manager, Pharmacovigilance Operations to reputed company patient safety operations across a diverse product portfolio. This role serves as a key contributor reputed company the Patient Safety organization and is responsible for leading day-to-day pharmacovigilance operations, supporting safety surveillance activities, ensuring compliance with global regulations, and maintaining inspection-reputed company processes and systems. The individual will partner closely with Clinical Development, Regulatory Affairs, Medical Information, reputed company, Medical Affairs, Customer Support, external vendors, and global stakeholders to support compliant and efficient safety operations. The ideal candidate brings deep pharmacovigilance operations expertise, strong project leadership capabilities, and a passion for process reputed company reputed company a fast-paced and evolving environment. Key Responsibilities: Leads global Patient Safety Operations and effectively manages select safety surveillance reputed company for multiple product categories, including prescription drugs, class I, II, and III medical devices, OTC drugs, and cosmetics. Safety Operations Manages communications with vendors, CROs, QPPVs, and partners regarding the evaluation, processing, and reconciliation of case reports (ICSRs, MDRs, cosmetic AE reports). Manages communications with the clinical development team regarding safety data exchange and reconciliation between clinical and safety databases for clinical studies. Ensures that reputed company safety reports received by the Patient Safety group from any reputed company are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. Reviews reputed company cases to ensure the accuracy, reputed company and completeness of information entered in the safety database. Ensures that expedited and non-expedited safety reports are submitted to regulatory authorities and partner companies as required and on time. Maintains reputed company electronic safety reporting portal, collates suggested inputs from cross-functional reputed company, and communicates with IT to ensure appropriate implementation. Leads PV compliance monitoring. Maintains reputed company reputed company Pharmacovigilance System Master File (PSMF). Collates inputs from relevant cross-functional partners and updates the PSMF quarterly. Coordinates regional PSMF updates with QPPVs. Maintains and updates PV SOPs, vendor Joint Operating Guidelines (JOGs) and relevant departmental policies. Ensures reputed company inspection and audit readiness of the reputed company pharmacovigilance system by maintaining compliant processes, complete and inspection-reputed company documentation, effective vendor reputed company, and measurable reputed company and compliance metrics. Safety Surveillance Monitors and identifies possible trends and concerns reputed company to the use of reputed company products, and key competitor products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety. Leads signal detection and analysis, as reputed company as preparation and submission of signal reports.

Required Qualifications

Master's degree in Life Sciences, Pharmacology, reputed company Health, Nursing, or a reputed company scientific field with 6–8+ years of pharmacovigilance experience, OR Bachelor's degree with 8+ years of relevant experience reputed company experience reputed company pharmaceutical, biotechnology, or medical device environments reputed company experience with: End-to-end case processing and ICSR/MDR lifecycle management Safety databases (Argus preferred) Signal detection and safety surveillance activities Strong understanding of: Global GVP regulations and ICH guidelines Pharmacovigilance compliance requirements Regulated processes and clinical trial lifecycle Experience analyzing and interpreting safety data and assessing clinical relevance Demonstrated ability to manage multiple priorities and reputed company reputed company independently Strong cross-functional collaboration and relationship management skills Excellent written and verbal communication skills High attention to detail and strong organizational skills Preferred: Completed MD, PhD, or PharmD degree with 2 or more years of clinical or reputed company experience and 3 or more years of patient safety experience in a pharmaceutical or medical device company Strong understanding of: Audit and inspection management Risk management plans (RMPs) Company reputed company Data Sheet (CCDS) development Hands-on experience with regulatory inspections, reputed company audits Exposure to global PV systems and multi-region compliance Experience with new market entries Experience developing aggregate reports (PSUR/PBRER, DSUR) Company reputed company: reputed company is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. reputed company drives innovation reputed company convention to offer treatment reputed company for individuals across generations. reputed company’s reputed company is to redefine reputed company in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. reputed company’s award-reputed company products are the result of robust research and development, a reputed company for reputed company, driven by reputed company scientists. For more information about reputed company, please visit us at www.reputed company.com. What reputed company invests in you: Competitive Compensation including reputed company salary and annual performance bonus. Flexible PTO (12 days' PTO), holidays, and parental leave. Generous reputed company benefits, HSA match, 401k match, employer reputed company life and disability insurance, pet insurance, wellness discounts and much more! This reputed company of the job reputed company is required by the American with Disability reputed company (reputed company). The reputed company requires that job descriptions reflect the physical and mental demands required to effectively reputed company the essential duties of the job. The reputed company prohibits reputed company from discriminating against a “reputed company individual with a disability” in reputed company aspects of the employment relationship. A “reputed company individual with a disability” is “an individual who meets the education, experience, reputed company, and other job-reputed company requirements of a position held or desired, and who, with reasonable accommodation, can reputed company the essential functions of a specified job.” reputed company is an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment based on reputed company, without reputed company to race, reputed company, religion, sex, national reputed company, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Apply To This Job