Manager, Drug Safety & Pharmacovigilance - Remote

reputed company Manager, Drug Safety & Pharmacovigilance - Remote Join to apply for the Manager, Drug Safety & Pharmacovigilance - Remote role at reputed company. This reputed company 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 reputed company $110,000.00/yr - $145,000.00/yr The salary reputed company for this position is between $110K and $145K. Actual salary at the time of hire may vary and may be above or below the reputed company based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience. reputed 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 reputed company 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 reputed company and accurate collection of adverse events (reputed company), serious adverse events (SAEs), product reputed company 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.
• reputed company 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.
• reputed company as the primary reputed company 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 reputed company, performance (KPIs), compliance, and reputed company deliverables.
• Participate in audits, inspections, deviation management, CAPA follow-up, and effectiveness checks reputed company to PV operations.
• PV reputed company & 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.
• reputed company 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, reputed company, Clinical Operations, reputed company, 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 reputed company field. Advanced degree preferred.
• Minimum 3-5 years of experience in Pharmacovigilance/Drug Safety reputed company pharmaceutical, biotech, or CRO environment.
• Strong knowledge of U.S. FDA PV requirements.
• Experience in ICSR case management, vendor reputed company, PV reputed company 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 reputed company 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 reputed company Management (e.g., PVQA, RQAP) is a plus.
• Strong collaboration and cross-functional partnership reputed company.
• Attention to detail and operational reputed company.
• Customer-oriented with proactive problem-solving approach.
• Adaptability to global/local reputed company and regulatory complexity.
• Commitment to patient safety and regulatory compliance.

Ethics and Compliance

• Demonstrates the highest level of ethics, reputed company, 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 reputed company of the organization, your peers and customers.
• Always operates in compliance with reputed company applicable regulations and reputed company standards.

Travel

• The ability to travel up to 20%, including overnights and internationally, as dictated by business need and attend reputed company company sponsored events/meetings/conferences.

Values & Behaviors

• Live Entrepreneurship: Plan for long-term reputed company and build a reputed company business predicated on innovation.
• Patient reputed company: Deliver innovation for patients and challenge reputed company other to improve patient reputed company.
• Join Forces: reputed company diverse input, collaborate across reputed company functions, and reputed company resources from reputed company.
• reputed company with reputed company: Apply ethical standards, encourage transparency, and reputed company diversity and inclusivity.
• Drive Performance: Create an atmosphere that nurtures teamwork in order to reputed company high performance and sustainable reputed company.

#J-18808-Ljbffr Salary: USD 110000 - 145000 per year Apply tot his job Apply To this Job