Vice President, Global Pharmacovigilance and Drug Safety | BioNJ Talent Services

Vice President, Global Pharmacovigilance and Drug Safety

Contact Information
Contact Name: 
PTC Therapeutics
Organization Name: 
PTC Therapeutics
Position Location: 
South Plainfield
Company Profile: 

Translating Science. Transforming Lives.

Our mission at PTC Therapeutics has always been to build an integrated biopharmaceutical company based on our expertise in RNA biology. We have focused on discovering and developing novel oral treatments for patients with serious and life-limiting disorders. By targeting the processes that modulate RNA biology and affect protein production, we bring an innovative approach to drug discovery. We are focused particularly on the development and commercialization of treatments for rare and neglected disorders.

Commitment to Patients.

We are committed to finding treatment options for patients living with life-threatening diseases. Our lead product candidate is ataluren for the treatment of patients with genetic disorders due to a nonsense mutation. Ataluren is in clinical development for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). Ataluren has been approved under the trade name Translarna™ in the European Union for ambulatory patients with nmDMD who are 5 years and older.

Job Description:

Job Description

The Vice President, Global Pharmacovigilance (PV) and Drug Safety (DS) is responsible for providing strategic and operation leadership for the Drug Safety/Risk Management/Pharmacovigilance functions. This includes providing leadership and global medical oversight for the Pharmacovigilance (PV) and Drug Safety (DS) processes and activities required at all stages of the product life cycle (clinical development through commercialization).
The incumbent manages, maintains and enhances compliance with PV/DS Standard Operating Procedures (SOPs); maintains and enhances Adverse Event (AE) guidelines and ensures the uniform and timely processing of AE reports; interacts with internal/external key stakeholders to continue the development of PV/DS programs (e.g., safety data agreements and processes that meet regulatory reporting requirements); prepares PV /DS reports for internal audiences as well as for external regulatory agencies; manages and conducts ongoing safety surveillance for PTC products across therapeutic areas and indications; and oversees and contributes to the preparation of required regulatory safety reports (e.g., Developmental Safety Update Reports (DSURs), Pharmacovigilance Safety Update Reports (PSURs), expedited safety reports), investigator communications, product labeling/package inserts, and other reports as required.
He/she also participates in, and contributes to, the safety oversight of ongoing clinical trials and registries and to the preparation of submission packages (electronic Common Technical Documents (eCTDs), New Drug Applications (NDAs)) with respect to PV/DS.
The incumbent works cross-functionally and serves as a liaison between the PV/DS team, other PTC departments, external service providers and contract manufacturers.
He/she also manages direct and indirect reports.
The Vice President, Global Pharmacovigilance and Drug Safety is accountable for adherence to relevant regulatory requirements and company SOPs as appropriate.

Primary duties and responsibilities:
Provides strategic leadership for the PV/DS program including, but not limited to: providing strategic consultation and guidance on all decisions that have significant drug safety implications and accountability for all relevant timelines and deliverables.
Establishes, manages, maintains and enhances PV/DS SOPs and procedures; may also deliver internal/external training to further ensure compliance with global PV/DS regulations.
Represents PV/DS functions on cross-functional clinical and commercial teams as well as with external stakeholders (i.e., investigators, Key Opinion Leaders [KOLs], regulatory authorities, collaborators, etc.); directs safety vendors for all global activities.
Collaborates with the Qualified Person for Pharmacovigilance (QPVV) located in the European Union (EU) and manages the information flow to/from the QPPV in accordance with European Medical Association (EMA) regulations and requirements.
Chairs the Global Safety Review Board (GSRB) consisting of the EU QPPV, the Deputy EU QPPV, and representatives from PTC’s Regulatory Affairs, Clinical Development, Commercial Operations, and Quality Assurance (QA) groups.
Functions as the product safety expert by performing proactive and ongoing evaluations of the overall safety profile for investigational products. This includes, but is not limited to: identifying and evaluating safety signals by assessing single case safety reports and aggregating/analyzing trends. These functions requires close collaboration with the physicians and clinical development teams to bring potential safety issues to light.
Performs, or provides direction for, the medical review of Serious Adverse Event (SAE) and AE reports to ensure accuracy, integrity, and completeness of safety information and to ensure the consistency of medical coding of safety data; supervises the AE intake and triage functions (currently outsourced) to ensure compliance with regulatory requirements; manages signal detection and risk management activities regarding safety signals as needed.
Reviews and provides input to responses to regulatory authorities regarding PV/DS activities.
Contributes to, reviews, and approves the safety sections of clinical documents including the safety portions of protocols, annual reports, final Clinical Study Reports (CSRs), Investigator Brochures (IBs), and other documents as required; supervises closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials; responsible for the final review and sign off with respect to all controlled documents.

Maintains current knowledge of global PV/DS regulations and guidelines.
Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of drug safety plans.
Manages coaches and mentors a group of direct and indirect reports.
Performs other tasks and assignments as needed and specified by management.

Qualifications: 

Essential Functions

Minimum level of education and years of relevant work experience

MD or advanced degree in Pharmacy with a minimum of 10 years of progressively strategic experience in Global PV/DS (including a minimum 5 years in a leadership role) in a pharmaceutical, biotechnology contract research organization (CRO) or related environment OR equivalent experience and/or education.

Special knowledge or skills 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.

Demonstrated knowledge of the drug development process (clinical development through commercialization).
Hands-on experience building a PV/DS organization/function including experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality (e.g., SAE reporting throughput rate).

Expertise using the Medical Dictionary of Regulatory Activities (MedDRA) dictionary for AE/SAE analysis and coding.
Expert, working knowledge of medical terminology and principles of clinical assessment of AEs/SAEs in the pharmaceutical industry including, but not limited to: experience evaluating and interpreting AE/SAE reports and other documents used in PV /DS submissions.

Demonstrated ability to identify opportunities to improve the PV/DS reporting processes. This includes communicating recommended changes to the sponsor’s study management and site monitoring staff.

Demonstrated ability to synthesize and analyze data.

Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.

Ability to influence without direct authority.

Proficiency with Microsoft Office.

Excellent verbal and written communication and skills.

Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.

Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Special knowledge or skills preferred

Experience interacting with health authorities.

Familiarity with PV/DS databases such as ARISg, AERS, and Argus.

Experience with transitioning from paper- and/or spreadsheet-based safety tracking systems to a fully compliant computerized solution.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Management