Term: 12-month contract role (with a view to permanency)
Responsible for the support of activities related to our client's Pharmacovigilance system, compliance with global Regulatory Health Authorities, adverse event reporting, safety contracts, and reconciliations. Role involves support for both commercially marketed and development products, and oversight of client’s distributors/vendors to ensure compliance.
Qualified Person for Pharmacovigilance (QPPV) and Deputy (QPPV)
- Support with oversight of services provided by our client’s pharmacovigilance vendor, ensuring compliance with local and global regulatory requirements.
- Review of CIOMS and Medwatch reports for accuracy and content prior to submission.
- Support global PV reporting obligations and tracking to regulatory authorities.
- Support, track and enhance existing standard operating procedures (SOPs) and controls.
- Build strong working relationships with internal stakeholders, PV vendor(s), and partners.
- Support the development and oversight of Safety Data Exchange Agreements (SDEAs).
- Support of risk mitigation measures and risk management plans (RMPs)
- Review and recommend safety related revisions to product labeling/investigational materials.
- Support PSMF oversight/management and revisions.
- Manage reconciliation process with partners.
- Respond/assist with inquiries from Regulatory authorities, vendor/partners, and distribution partners.
- Ensure compliance with regulatory reporting obligations related to products and development candidates.
- Review/revise/communicate metrics relative to PV system performance/compliance.
- Oversight of literature review in support of safety management systems and regulatory reporting.
- Support safety review and assessments of clinical data on development candidates. Assist in preparation of regulatory submissions in support of development programs.
- Assist in the conduct of business diligence activities for new partners.
- Support for Regulatory Authority audits/inspections related to pharmacovigilance.
- Support signal detection process.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Minimum of 2-3 years direct pharmacovigilance or regulatory experience, preferably with pharmaceuticals and/or biologics.
- Minimum bachelor’s degree in science-related discipline or medical field (RN, Pharm etc.).
- Demonstrated experience in pharmaceutical drug product, device, and biologics.
- Proficiency and understanding in use of Argus Oracle Drug Safety Database or similar safety database.
- Experience in Drug Safety Applications and Regulatory compliance applications,
- Knowledge of FDA guidelines, EMA GvP modules, and Canadian PV regulations
- Demonstrated experience in the review of Individual Case Safety Reports (ICSRs)
- Understanding of pharmaceutical product development.
- An ability to contribute to a team environment.
- Excellent organizational and relationship management skills
- Excellent oral and written communication skills.
- Strong knowledge of PV quality systems and regulatory requirements across US/Canada.
- Strong technical and problem-solving skills.
- Experience with rest of world PV requirements (multi-country).
- Experience in development safety assessments
- Regulatory Authority inspection experience.
Position may include US/Canada or other global partner location