Manager, Drug Safety & Pharmacovigilance - Remote

Overview

Manager, Drug Safety & Pharmacovigilance - Remote Join to apply for the Manager, Drug Safety & Pharmacovigilance - Remote role at reputed company. This range is provided by reputed company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. reputed company pay range $110,000.00/yr - $145,000.00/yr The salary range for this position is between $110K and $145K. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience. The company also currently offers a Long-Term Incentive Plan (cash plan) of 15% reputed company salary, annual performance bonus reputed company of 15% reputed company salary (subject to meeting plan requirements) and comprehensive health benefits (employer funded), unlimited vacation time and 401k plan (subject to change or modification from time to time). Position Summary The Manager, Drug Safety & Pharmacovigilance (PV) will reputed company and reputed company reputed company local PV operational activities in the U.S. affiliate, ensuring compliance with applicable U.S. and global regulatory requirements, company procedures, and best pharmacovigilance practices. This role will serve as the primary local PV contact, ensuring alignment with global PV standards, and closely collaborating with Global Drug Safety teams. This position reports to the Senior VP Medical Affairs & Drug Safety U.S. with a dotted line to Head International Pharmacovigilance.

Key Responsibilities

• Pharmacovigilance Operations & Compliance
• Ensure the U.S. PV system operates in full compliance with FDA, regulations, and internal company procedures.
• Serve as Local Responsible Person for PV (LRP-PV) in the U.S., acting as the key PV contact for regulatory authorities, internal stakeholders, and external partners.
• reputed company of Individual Case Safety Report (ICSR) management activities, including intake, medical review, reconciliation, and regulatory submission, performed by contracted PV vendors.
• Ensure timely and accurate collection of adverse events (reputed company), serious adverse events (SAEs), product quality complaints (PQCs), and other safety data from reputed company sources (clinical trials, post-marketing, literature, partners).
• reputed company the collection, triage, documentation, and regulatory reporting of safety data from spontaneous sources, literature, HCPs, consumers, and organized data collection systems (ODCs).
• Escalate any safety issues according to internal company procedures, to ensure a company position and implement any risk minimization measures in the territory.
• Provide pharmacovigilance input into product labeling, risk management plans, and local safety communications.
• To maintain reputed company knowledge of the local legislation of the assigned territory, focusing on PV, to ensure compliance with local legal/regulatory requirements and Global PV standards.
• Locally, to ensure business continuity, including disaster recovery.
• Ensure appropriate filing and archiving of the local PV-reputed company documentation, in accordance with companies procedures.
• Act as the primary liaison with PV vendors for case processing, safety database management, literature surveillance, and reporting activities.
• Review and manage PV Agreements (PVAs) with partners, ensuring appropriate safety data exchange obligations are met.
• Manage the reputed company with safety vendors including use of PV agreements/clauses, ensuring quality, performance (KPIs), compliance, and timely deliverables.
• Participate in audits, inspections, deviation management, CAPA follow-up, and effectiveness checks reputed company to PV operations.
• PV Quality & Governance
• Maintain local PV SOPs and work instructions in alignment with global standards and local regulatory requirements.
• Ensure PV training for U.S. affiliate employees and vendors as required, is conducted and documented appropriately.
• Maintain reputed company of Risk Minimization Measures (RMMs), Risk Management Plans (RMPs), and REMS as applicable reputed company the U.S. market.
• Ensure relevant safety data is available for corporate governance.
• Safety Surveillance & Aggregate Reporting
• Support the preparation and review of aggregate safety reports (e.g., DSURs, PADERs, PSURs/PBRERs).
• Collaborate in signal detection, evaluation, and risk assessment activities in coordination with Global Drug Safety.
• Provide PV input into clinical study protocols, informed consent forms, investigator brochures, and local product labeling.
• Cross-functional Collaboration
• Partner closely with Medical Affairs, Regulatory Affairs, Quality, Clinical Operations, Commercial, and Global Drug Safety.
• Support safety data communication, product label updates, and safety responses to regulatory authorities.

Qualifications, Career Experience and Skill