Location: Taguig, Philippines - Hybrid 3 days/week
Area Safety Officer Pharmacovigilance
Kelly FSP is seeking a skilled Area Safety Officer to join our client's team. This opportunity is ideal for professionals who excel in compliance, risk management, and product vigilance at both local and global levels.
Key Responsibilities
- Serve as the Local Nominated Person for Pharmacovigilance, acting as the primary safety contact in accordance with national laws and regulations.
- Monitor and assess regulatory changes to maintain ongoing compliance.
- Liaise with internal teams, vendors, distributors, and third parties to reconcile safety data and report findings promptly.
- Oversee the identification and review of local literature for Adverse Event (AE) reporting, ensuring thorough document management and archiving.
- Prepare, submit, and manage safety reports (e.g., SAE, SUE, SUSARs, PSURs, RMPs) for health authorities and key stakeholders.
- Respond to health authority inquiries and notifications regarding safety concerns.
- Maintain comprehensive knowledge of local pharmacovigilance, cosmetic, and device vigilance requirements, adapting quickly to regulatory updates.
- Record and manage non-conformances, and work with global teams to develop and implement effective Corrective and Preventative Action (CAPA) plans.
- Deliver specialized training on safety reporting and best practices to local staff.
- Translate safety documents as required for local and international teams.
- Develop, update, and implement procedures in alignment with global and local standards.
- Support audits and inspections by health authorities, and contribute to business continuity planning.
Additional Responsibilities
- Draft and provide pharmacovigilance clauses for inclusion in local contracts and agreements.
- Undertake additional duties as assigned by management.
Qualifications
- Degree in a healthcare-related field (e.g. nursing, pharmacy, life sciences) or equivalent experience and training.
- 2 years of relevant experience in the pharmaceutical industry, ideally with a focus on product vigilance.
- Strong foundation in medicine, pharmacy, clinical practice, or related science disciplines.
- Excellent understanding of medical terminology.
- Tech-savvy with solid IT and computer skills.
- Proficient in both local language(s) and English.
- Exceptional verbal and written communication skills.
- Collaborative team player, able to build productive relationships internally and externally.
Why Join Us This is an exciting opportunity to make a tangible impact on public health and work with a team dedicated to safety and regulatory excellence. If you have a passion for compliance and pharmacovigilance, apply today and advance your career with us!
