Manager, Pharmacovigilance Operations
The Pharmacovigilance Operations Manager is responsible for ensuring efficient and compliant processes are in place to allow timely collection and reporting of patient safety data. This includes oversight of Case Management, Drug Safety Systems, Alliance and Vendor Management, and Submissions Compliance.
The Pharmacovigilance Operations Manager will act as a liaison with internal departments and external business partners on pharmacovigilance (PV) operational issues and clinical study related activities, such as: represent GPS on study teams, oversee case processing activities, draft/review safety/clinical related documents as required.
Specific responsibilities include:
- Oversee case processing vendor activities, ensuring ICSRs are of high quality, completed and adhered to the agreed processing timelines in order to support timely submissions/distributions to global recipients within required timelines.
- Act as a liaison with internal departments and external business partners on PV operational issues and clinical study related activities.
- Contribute to the draft/review/update of drug safety related forms, documents and templates (i.e., SAE data collection form, Safety management plans, SAE reporting plans, aggregate/periodic safety reports, etc.).
- Contribute to the draft/review/update of safety sections of study protocols, Investigator’s Brochure, Inform Consent Forms, etc.
- Support signal detection and risk management activities.
- Represent PV in study management teams for assigned studies.
- Manage SAE reconciliation activities between clinical and safety databases.
- Assist with data-lock activities, ensuring that all cases in the Safety database are complete and all outstanding queries are resolved and closed.
- Support the development and implementation of PV process improvements, tools, systems and procedures to enable excellence and consistency in PV activities in collaboration with other stakeholders.
- Support the oversight, management, and communication for all future global business partner Safety data exchange agreements and other contracts as applicable, while ensuring compliance with data exchange activities.
- Participate in vendor and technology evaluation, qualification and selection.
- Cultivate effective and productive working relationships with colleagues, vendors and management. Uses clear judgment to solve problems and escalate issues with proposed solutions, as necessary.
- Ensure compliance with SOPs and global regulations, GCP, ICH guidelines and Good Clinical Practices internally and by vendors.
- Participate in SOP development, training, process mapping, and other departmental activities.
- Ensure PV activities and procedures are in an inspection-ready state.
- May support Health Authority inspections and internal audits to ensure the quality, integrity and compliance with safety reporting requirements, including authoring of relevant responses to findings.
- Health care professional background (Nursing, Pharmacy, Medicine or equivalent), or
- BS/BA degree in a health related or biological science related field, or
- Equivalent combination of education and experience
- Minimum of 4 years of experience in Drug Safety/Pharmacovigilance, or equivalent experience in pharma/biotech is required
- A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
- Experience with Drug Safety databases, as well as MedDRA and WHO DD knowledge are required
- Previous experience in a small-company environment and collaborating/communicating with partner companies a plus
- Proficiency with MS Word, Outlook, PowerPoint, and other computer programs
- Excellent interpersonal, organizational, and communication (oral and written) skills
- Ability to work effectively in both a team setting and independently with minimal oversight
- Demonstrated ability in logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities
- Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude