Overview Manager, Drug Safety & Pharmacovigilance - Remote Join to apply for the Manager, Drug Safety & Pharmacovigilance - Remote role at Averitas Pharma. This range is provided by Averitas Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base 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% base salary, annual performance bonus target of 15% base 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 lead and oversee all 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. • Oversight 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 (AEs), serious adverse events (SAEs), product quality complaints (PQCs), and other safety data from all sources (clinical trials, post-marketing, literature, partners). • Oversee 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 current 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-related 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 interface 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 related 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 oversight of Risk Minimization Measures (RMMs), Risk Management Plans (RMPs), and REMS as applicable within 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 Skills A combination of relevant education and applicable job experience will be considered. Qualifications • Bachelor's or Master's Degree in Life Sciences, Pharmacy, Nursing, or related field. Advanced degree preferred. • Minimum 3-5 years of experience in Pharmacovigilance/Drug Safety within pharmaceutical, biotech, or CRO environment. • Strong knowledge of U.S. FDA PV requirements. • Experience in ICSR case management, vendor oversight, PV quality systems, audits, and inspections. • Strong organizational, analytical, and problem-solving skills. • Excellent communication skills, both written and verbal. • Ability to operate independently, manage multiple priorities, and navigate in a matrix global organization. • Prior experience managing PV operations in an affiliate of a global company. • Experience in both clinical development and post-marketing pharmacovigilance. • Certification in Pharmacovigilance or Quality Management (e.g., PVQA, RQAP) is a plus. • Strong collaboration and cross-functional partnership mindset. • Attention to detail and operational excellence. • Customer-oriented with proactive problem-solving approach. • Adaptability to global/local interface and regulatory complexity. • Commitment to patient safety and regulatory compliance. Ethics and Compliance • Demonstrates the highest level of ethics, integrity, trust while acting with courage and candor. • High accountability for your actions and results and ability to ensure a high level of commitment to the success of the organization, your peers and customers. • Always operates in compliance with all applicable regulations and professional standards. Travel • The ability to travel up to 20%, including overnights and internationally, as dictated by business need and attend all company sponsored events/meetings/conferences. Values & Behaviors • Live Entrepreneurship Plan for long-term growth and build a future business predicated on innovation. • Patient Centric Deliver innovation for patients and challenge each other to improve patient outcomes. • Join Forces Seek diverse input, collaborate across all functions, and leverage resources from global partners. • Act with Integrity Apply ethical standards, encourage transparency, and embrace diversity and inclusivity. • Drive Performance Create an atmosphere that nurtures teamwork in order to enable high performance and sustainable growth. #J-18808-Ljbffr Salary USD 110000 - 145000 per year Apply To This Job Apply To this Job Apply To this Job