Director, Pharmacovigilance Physician

Job Description Summary:

The Director, Pharmacovigilance Physician performs the signal detection and surveillance for products defined by the Head of PV. This involves providing scientific/clinical pharmacovigilance (PV) expertise with a focus on the identification, evaluation and management of safety risks for specified PTC Therapeutics’ marketed and investigational products throughout the product lifecycle. He/she also contributes to the medical review of individual case safety reports and follow-up questions for Adverse Event reports received from clinical trials and post-marketing surveillance in compliance with Good Clinical Practice (GCP), company Standard Operating Procedures (SOPs), and other applicable guidelines and regulations as appropriate (e.g. 21 CFR Parts 312 and 314 and European Medicines Agency (EMA) Clinical Trials Directive and GVP modules).

The incumbent works cross-functionally with internal departments and external resources on PV related issues.

The Director, Pharmacovigilance Physician supports adherence to relevant regulatory requirements and company SOPs as appropriate.
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Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Performs medical review of all Individual Case Safety Report from clinical trials and post-marketing sources.

• Contributes to, reviews and/or approves safety aggregate reports (Periodic Safety Update Reports, Development Safety Update Report, Ad-hoc report, Topic report, Periodic Adverse Drug Evaluation Report, etc.).

• Chairs the Safety Review Board for PTC investigational and marketed products periodically and on ad-hoc basis, as needed.

• Performs monthly and quarterly signaling to identify, validate and communicate signals and record in the appropriate documentation (e.g. signal tracker). Authors Risk Tracking Document and reviews/ contributes to the Risk Management Plans and Addendums.

• Provides oversight of PV CRO with regards to medical surveillance activities.

• Contributes to the development, implementation and on-going enhancement of safety surveillance processes and the associated SOPs.

• Collaborates with Regulatory Affairs to ensure appropriate reporting of PV information to regulatory agencies in a timely manner.

• Directs and provides key input for, the review of new or ongoing safety documents that ensure compliance with domestic and international regulatory requirement that include, but may not be limited to, protocols, study reports, briefing books and questions from regulatory authorities.

• Provides input for the preparation and/or review of Reference Safety Information in Investigator Brochures (IBs), Core Data Sheet, Local Label updates, etc.

• Represents the PV function in development project teams and provides clinical guidance for pharmacovigilance activities through internal collaboration with Regulatory Affairs, Biostatistics, Clinical Operations/ Research, Commercial and Quality Assurance (QA) and others, as necessary.

• Provides input and/or review of all life cycle management submissions to world-wide health authorities for PTC marketed products.

• Provides support to health authority inspections, FDA Ad-com and other related activities for PTC investigational and marketed products.

• Performs other tasks and assignments as needed and specified by management.

• Represents PV and PTC at Regulatory Authority oral hearings and Advisory Committee meetings.

• Provide medical assistance to the EU QPPV as required (as per GVP Module I).

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• Medical degree e.g. MBBS, MD or DO degree and a 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

* Special knowledge or skills needed and/or licenses or certificates required.

• Expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing drug safety reporting and PV/DS in the conduct of clinical trials.

• Extensive working 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 development of Risk mitigation strategies.