Senior Safety Officer Porto Salvo

Contract: 12 months

On behalf of our client, a global leader in consumer health, we are seeking Senior Area Safety Officer. In this role you will be responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/ procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.

Responsibilities

• Provide oversight of vendor resources within Portugal, Spain, Andorra, Italy, San Marino, Vatican City, Greece and Cyprus.
• Support the Area Safety Head in providing relevant local information for the European Economic Area Pharmacovigilance System Master File.
• Record
  - identified
  - conformances and collaborating with the global team to investigate
  - conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).
• Receive and support the Area Safety Head in the responses to
  - related health authority queries.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required.
• Perform document management and archiving as required.
• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI/ ESI and signals.
• Manage reporting/ submissions of safety reports/ updates/ information (e. g. , SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other departments as applicable.
• Maintain
  -
  - date knowledge of local requirements for pharmacovigilance, cosmetovigilance, materiovigilance and nutrivigilance, including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
• Ensure pharmacovigilance compliance of local company sponsored programs and research activities as applicable.
• Perform translation for ICSR and PV-related documents, as required.
• Provide technical and strategic input and participate in projects/ workstreams led by the
• Develop, update, and implement local procedures to ensure compliance with global procedures and national requirements.
• Ensure current knowledge of all relevant company procedures and training.
• Support local health authority inspections and audits conducted locally, including preparing and responding to queries during the conduct and collaborating with the global team to develop and implement CAPA plans as applicable.
• Management of vigilance contracts and clauses:
  - up, revision, internal tracking and periodic reconciliations.
• Ensure implementation of local business continuity plans (e. g. , inspection readiness, AE reporting coverage).

Qualifications

• Health care science professional e. g. : (Pharmacist, nurse…)
• At minimum 3 years’ experience.
• Pharmaceutical industry experience including product vigilance responsibility role.
• A previous experience as Local Safety Officer in Portugal would be a real added value.
• Proven ability to organize workflow activities.
• Computer literate with knowledge of relevant IT safety systems.
• Good verbal and written communication skills.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Demonstrable knowledge of local requirements and global aspects of product safety.
• Mother tongue: Portuguese
• Fluency in the English language is required.

Seniority level

• Mid‑Senior level

Employment type

• Full‑time

Job function

• Consulting
• Industries
• Pharmaceutical Manufacturing