Drug Safety Manager Lazio

Drug Safety Manager
Roma
Lazio, Lazio

We are currently seeking a Drug Safety Manager for a CRO based in Italy with multiple offices in the UK and Italy, they are looking to add to their consulting unit with a new hire.

They offer flexible working with training opportunities, conferences and more plus a generous salary and working benefits.

**Responsibilities**:

- Manage PV & Safety projects and/or staff allocated to those projects.

- Act as Project Manager for assigned projects/contracts and provide regular updates to the PV & Safety Director.

- Oversee project phases and deliver against milestones within budget and on time.

- Supervise and train junior staff, directly or through functional relationships.

- Participate in workflow development and strategic planning for PV Services.

- Develop and implement Safety & Project Plans and Safety Management Plans for Project/Client specific AE workflows and Services.

- Perform scientific literature screening.

- Update the PV archive with required documentation (either in paper or electronic).

- Register the Company on behalf of the Client in Eudravigilance when required by the project.

- Enter/report ICSRs and SUSARs to Eudravigilance via EVWEB (only if trained by a certified person or after completing the Eudravigilance course).

- Ensure preparation and submission of PSURs and DSURs according to relevant rules and agreed deadlines with the Client.

- Prepare and revise Safety Data Exchange Agreements/PV Agreements.

- Assist the PV physician in the Signal Detection/Management process.

- Assist in developing new standard operating procedures and work guidance and/or review Client SOPs, if applicable, for full compliance.

- Assist in ensuring audit/inspection readiness.

- Track compliance metrics.

- Assist in identifying and following up on corrective action plans arising from audits and inspections.

- Participate in training development programs for cross-functional personnel and external groups in drug safety principles and practices.

- Assist the PV Physician in developing Study Protocols, IBs, IMPDs, RMPs.

- May cover the role of QPPV and Deputy and Italian Local Contact Person for PV.

Background & Experience:

- University Degree in Scientific Subject

- At least 2-3 years (DSM) or 5 years (Senior DSM) of experience in PV Operations, including case processing, Pharmacovigilance Agreement writing, and literature screening.

- Proficient in English.

- Experience in GVP regulatory compliance

- Knowledge of Regulatory guidelines worldwide.

- Familiarity with Regulatory standards applicable to Pharmacovigilance.

Contratto di lavoro: Tempo pieno

Retribuzione: €40. 000, 00 - €50. 000, 00 all'anno

Orario:

- Dal lunedì al venerdì

- No weekend

Requisito linguistico flessibile:

- Italiano non richiesto