PV Affiliate, Drug Safety Associate

About the role

Astellas is looking for a PV Affiliate / Drug Safety Associate based in Bogotá D.C., working on site in a hybrid arrangement. The role works with the RAPV Affiliate Lead and Drug Safety Officer (DSO) to uphold excellence in pharmacovigilance at the local affiliate, acts as the DSO's back-up and deputy of the local qualified person for PV (if applicable), and reports to the RAPV Affiliate Team Lead Colombia.

Key responsibilities

• Take care of ICSR case intake and local processes, including coordinating the PV vendor for timely submissions and reviewing spontaneous safety information via the Global Safety Database (GSD)
• Maintain PV logs and databases, write and update local PV processes and standards, and run routine database reconciliations and quality checks
• Ensure correct electronic and hard-copy filing and archiving of documents, and keep local quality documents up to date
• Support PV agreements and contracts with local vendors, and take corrective or preventive action on late reporting
• Participate in PV projects, represent the department in inspections and audits, and follow the business continuity plan
• Contribute to 24/7 availability for urgent safety issues and guide junior colleagues or vendor staff, giving PV training as needed
• Collaborate with healthcare professionals, the affiliate lead, clinical operations, regulatory affairs, medical affairs, marketing, sales and other functions, and with RAPV headquarters

Required profile

• Minimum BA/BS degree in Health Science, Life Science or Medical Science
• At least 2 years of relevant experience in pharmacovigilance, or combining PV/RA/QA and/or clinical development
• Good knowledge of local PV requirements and regulations, and ability to turn regulations into business requirements
• Strong industry perspective, excellent time management and organizational skills
• Fluent written and spoken business English and Spanish