Senior Pharmacovigilance Lead & Safety Strategist

Parexel; Manila; On-site; PHP 558,000 - 837,000; Full time

Job summary

A leading global biopharmaceutical services firm is seeking a Regulatory Affairs Specialist in Manila. This role requires expert knowledge of drug safety regulations and the ability to provide technical guidance. Responsibilities include managing regulatory applications and submissions, ensuring compliance with global standards, and collaborating with cross-functional teams. Ideal candidates will have a degree in Pharmacy or related fields and proven experience in safety case management.

Qualifications

• Proven experience in safety case management and regulatory reporting.
• Proficiency with safety databases and data analysis.
• Strong knowledge of ICH guidelines and regional requirements.

Responsibilities

• Maintain expert-level knowledge of safety profiles, labeling, and global regulations.
• Lead development of project-specific procedures and workflows.
• Manage regulatory applications and submissions across multiple regions.

Skills

Expert knowledge of drug safety regulations and pharmacovigilance processes

Strong analytical and problem-solving abilities

Excellent communication and presentation skills

Superior organizational and time management capabilities

Proficiency with pharmacovigilance systems and databases

Education

Degree in Pharmacy, Nursing, Life Science, or health-related field

Job description

A leading global biopharmaceutical services firm is seeking a Regulatory Affairs Specialist in Manila. This role requires expert knowledge of drug safety regulations and the ability to provide technical guidance. Responsibilities include managing regulatory applications and submissions, ensuring compliance with global standards, and collaborating with cross-functional teams. Ideal candidates will have a degree in Pharmacy or related fields and proven experience in safety case management.