Area Safety Officer-Pharmacovigilance

• Function as nationally nominated person or back up for the local nominated person for Pharmacovigilance in respective countries assuming the PV role as defined by national law if applicable.

Safety Management & Reporting

• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for AE reporting as required.
• Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other departments as applicable.
• Receive and support the Area Safety lead in the responses to safety-related health authority queries in the territory.
• Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/Client and Signals.
• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances 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.
• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
• Perform other agreed tasks assigned by the manager.
• Perform document management and archiving as required.
• Perform training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Perform translation for ICSR and PV-related documents, as required

Procedural Document

• Develop, update, and implement local procedures to ensure compliance with client procedures and national requirements.
• Ensure current knowledge of all relevant company procedures and training.

Audit & inspection readiness

• Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventive Action) plans as applicable.

PV contract management

• Provide PV clauses to be included within local agreements.

Business Continuity

• Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).

Education

• Health care science professional e.g.: (nurse, pharmacist, life science degree) or equivalent training and experience
• Years of Related Experience: 1-2 years experience ICSR Pharmacovigilance is needed.

Knowledge, Skills, Abilities:
Include any required computer skills, certifications, licenses, languages, etc.

• Pharmaceutical industry experiences including product vigilance responsibility role.
• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.
• Sound knowledge of medical terminology
• Good verbal and written communication skills.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Fluency in the national language(s) and the English language.