Director, Pharmacovigilance Physician

January 22

Apply Now

Receive Emails with Similar Jobs

PTC Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

PTC is a patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for children and adults living with rare and serious disease.

Orphan and Ultra-orphan Disorders • Oncology • Anti-infectives

501 - 1000 employees

Founded 1998

📋 Description

• Performs signal detection and surveillance for defined products. • Provides scientific/clinical pharmacovigilance expertise on safety risks. • Contributes to medical review of individual case safety reports. • Works cross-functionally on PV related issues. • Chairs the Safety Review Board for PTC products as needed. • Conducts monthly and quarterly signaling to identify safety signals. • Authors and reviews Risk Tracking Document and Risk Management Plans. • Collaborates with Regulatory Affairs for PV reporting to regulatory agencies. • Provides input for review of safety documents for compliance. • Supports health authority inspections and related activities. • Represents PV function at Regulatory Authority oral hearings and Advisory Committee meetings.

🎯 Requirements

• Medical degree e.g. MBBS, MD or DO degree. • Minimum of 8 years of progressively responsible related experience (minimum 7 years in a PV role) in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment. • Expert knowledge of FDA, EU, and ICH guidelines, initiatives and regulations governing drug safety reporting and PV/DS in clinical trials. • Extensive knowledge of medical terminology and principles of clinical assessment of AEs/SAEs in the pharmaceutical/biotechnology industry. • Expertise in Medical Dictionary of Regulatory Activities (MedDRA) with relevance to AE/SAE coding. • Expert in Risk Benefit Assessment and risk mitigation strategies. • Hands-on experience identifying, developing and implementing improvements to departmental processes. • Ability to influence without direct authority. • Proficiency with Microsoft Office. • Excellent verbal and written communication skills. • Ability to work independently and collaboratively in a fast-paced environment. • Analytical thinker with problem-solving skills. • Excellent planning and organization skills.

🏖️ Benefits

• Short- and long-term incentives. • Medical, dental, vision, and retirement savings plans.