Posted in Science 30+ days ago.
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Location: SOUTH PLAINFIELD, New Jersey
PTC is a science-led, global biopharmaceutical company focused on the discovery, development and commercialization of clinically-differentiated medicines that provide benefits to patients with rare disorders. Founded over 20 years ago, PTC Therapeutics successfully markets rare disorder products and has a robust pipeline of transformative medicines. When you combine great causes with great people, you find a culture that thrives on collaboration and creativity. PTC is a committed group of people that have a passion for science and a strong desire to succeed in an environment that is rewarding, inclusive and respectful. Join us on our journey as you grow your career.
The Associate Director, Pharmacovigilance performs the function of Safety Scientist within the Pharmacovigilance (PV) department for both clinical trials and post-marketing surveillance support for PTC products.
He/she leads, project manages, and actively contributes to, but not limited to the development of aggregate reports, signal detection activities safety review board, and risk management plans.
The incumbent works cross-functionally with internal departments/key stakeholders and external resources on pharmacovigilance-related matters to adhere to global pharmacovigilance regulations and requirements.
The Associate Director, Pharmacovigilance – Safety Scientist ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
*Is responsible for assigned product(s) or therapeutic area pharmacovigilance activities.
*Functions as the overall project manager for compiling pharmacovigilance aggregate reports including, but not limited to, Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER), topic reports.
*Collaborates with safety physician to ensure effective planning such that stakeholder input is requested/received for applicable sections of pharmacovigilance reports to meet regulatory reporting deadlines.
*Contributes to relevant sections of pharmacovigilance safety reports in collaboration with the safety physician.
Provides training and guidance to other functions to address ad hoc questions and issues pertaining to pharmacovigilance safety reports.
*Leads the review and approval process for all pharmacovigilance reports working in conjunction with safety physician and external pharmacovigilance vendor.
*Functions as the overall project manager for compiling safety information for Clinical Overviews, responses to regulatory questions, post-marketing safety assessment, Risk Management Plans, labeling justifications, Company Core Safety Information (CCSI) development, Investigator Brochures (IBs) update, label update(s) as well as written summaries of clinical safety of Common Technical Document (CTD).
*Provides and ensures oversight for the technical and scientific support for safety surveillance and signal detection activities for PTC products.
*Provides planning for, and ensures the conduct of, and leads (with the safety physician) routine and ad-hoc cross-functional Safety Review Board (SRB) meetings on a periodic and ad-hoc basis. Collects and ensures key stakeholder input is gathered and presented for discussion/decisions.
*Contributes to the update of Risk Management Plans (RMPs) and ensures that regulatory and RMP commitments are efficiently tracked and presented as part of the SRB process. Liaises with SRB chair/s to facilitate communication and support for decisions resulting from the SRB. (e.g. update of RMPs, labeling, regulatory notifications or other actions as required).
*Collaborates with key stakeholders outside of PV. Represents PV department in cross-functional clinical program teams, providing support to development programs and registration activities.
*Collaborates with medical monitor(s), safety physician and Regulatory Affairs to process, review, submit, track and monitor expedited safety reports to appropriate domestic and international regulatory authorities within required timelines.
*Provides support to Drug Safety Monitoring Board and clinical trial support.
*Participates in and, as necessary, actively contributes to, investigator meetings.
*Interfaces with medical monitors for medical assessment and regulatory classification of SAEs; manages and facilitates SAE reconciliation across projects
*Serious adverse event follow-up and case closure.
*Performs other tasks and assignments as needed and specified by management.
Minimum level of education and years of relevant work experience.
BSN/RN or Bachelor’s in Pharmacy or Life Sciences and a minimum of 8? years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment.
Special knowledge or skills needed and/or licenses or certificates required.
*Demonstrated, expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
*Experience in scientific writing; project management; leading and contributing to required safety reports, etc.
*Extensive working knowledge of medical terminology and Medical Dictionary of Regulatory Activities (MedDRA).
*Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
*Proficiency with Microsoft Office and 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.
*Ability to influence without direct authority.
Special knowledge or skills and/or licenses or certificates preferred.
*Expertise in the use of Electronic Document Management System (eDMS) software.