Home /
Author / Mary Pilkington, PhD
Mary Pilkington, PhD
Associate Director, Service Line Head, CertaraMary Pilkington, PhD, has over 20 years of experience in regulatory writing. She is an expert in writing pharmacovigilance documents, including development safety update reports, periodic benefit-risk evaluation reports, periodic adverse drug experience reports, and risk management plans. She is process-driven, having created standard operating procedures and working instructions for pharmacovigilance documents, and is client-oriented, developing long-term governance relationships. She also has proven skills in training and developing junior writers to become pharmacovigilance document subject matter experts. She is an associate director and the service line head for safety/PV at Certara.