Pharmacovigilance Specialist
1 week ago
We're seeking a highly skilled Pharmacovigilance Associate to join our team at Lilly.
About the RoleThe purpose of this role is to ensure compliance with internal and external requirements concerning Pharmacovigilance in Australia and New Zealand.
Key Responsibilities- Execute pharmacovigilance activities as required, including adverse event management, expedited and periodic reporting, risk management, and creation and maintenance of the Pharmacovigilance System Master File.
- Ensure appropriate interpretation and implementation of national pharmacovigilance legislation/regulation for both drugs and devices.
- Liaise with regulatory authorities, work with legal, quality, medical, and regulatory teams on safety issues as needed.
- Provide input to local Risk Management Plans and local risk minimization activities.
- Ensure local business alliance and third-party safety agreements are in place, up to date, and followed as required.
- Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise awareness of pharmacovigilance as needed.
- Submit other pharmacovigilance documents to the national authority and Ethics Review Board as required.
- Serve as point of contact for reception and collection of Adverse Event reports and manage database.
- Responsible for the accuracy and completeness of adverse event reports from post-marketing programs and spontaneous sources for marketed products and devices.
- Responsible for the submission of case reports to national regulatory authorities.
- Reconciliate case reports with business partners, medical information, and product quality.
- Strive for inspection and audit readiness and participate in inspections, audits, and assessments.
- Ensure relevant safety standard operating procedures (SOP) are well understood across the business, lead, and provide clarification on local implementation where applicable.
- Support the development of global SOPs to ensure alignment with local laws and regulations.
- Bachelor's degree in a health profession (i.e., Pharmacy, Nursing) or life science field or equivalent demonstrated experience in patient safety.
- Experience working with local, regional, and global procedures.
- Knowledge of legislation with regards to relevant national regulatory guidelines, directives, and regulations in Pharmacovigilance. Excellent communication (written and verbal), interpersonal, organizational, and negotiation skills.
- Strong knowledge of quality management systems.
Lilly is an equal opportunities employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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