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Pharmacovigilance Specialist
2 months ago
We're seeking a highly skilled and dedicated individual to join our team as a Pharmacovigilance Associate. This is a fixed-term 12-month parental leave cover role, providing an excellent opportunity to gain valuable experience in the field of pharmacovigilance.
Key Responsibilities:- Execute pharmacovigilance activities, including adverse event management, expedited and periodic reporting, risk management, and creation and maintenance of the Pharmacovigilance System Master File.
- Ensure compliance with national pharmacovigilance legislation and regulations 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 for employees and/or business alliance partners on pharmacovigilance awareness.
- Submit pharmacovigilance documents to national authorities and Ethics Review Board as required.
- Serve as the point of contact for adverse event reports and manage the database.
- Responsible for the accuracy and completeness of adverse event reports from post-marketing programs and spontaneous sources.
- Responsible for submitting 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 are well understood across the business.
- 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 regarding national regulatory guidelines, directives, and regulations in pharmacovigilance.
- Excellent communication, interpersonal, organizational, and negotiation skills.
- Strong knowledge of quality management systems.
Lilly is an equal opportunities employer and welcomes applications from diverse candidates. We do 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.
