PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
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Site: www.ptcbio.com
The Associate Director, Pharmacovigilance Operations oversees Pharmacovigilance Operations activities, both internally supported and outsourced, including the collection, processing, assessment, monitoring and follow-up of all types of safety information from various sources, including clinical trials and post-marketing, and any other PV Vendor deliverable
The incumbent ensures all relevant Pharmacovigilance guidelines / regulations are adhered to and works cross-functionally with internal departments and external resources on ICSR and safety database related matters. This includes providing strategic and operational oversight of PTC’s Pharmacovigilance (PV) vendor.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
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Leads, oversees and actively contributes to the development, implementation and maintenance of a robust safety reporting system compliant with current applicable regulations. This includes closely managing the PV vendor and the case workflow, reviewing samples of cases to ensure ICSR quality and compliance with regulatory timeframes.
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Supports training the PV vendor on new products and compliance requirements.
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Supports PV set up and implementation of new studies / programs, including interventional Clinical Trials and Post-authorisation safety studies.
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Reviews and contributes to PV vendor operational documentation, e.g. operational plans, program specific work-instructions.
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Oversees safety database configuration, ensuring it meets applicable regulations and program needs.
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Ensures the quality, completeness and timeliness of delivery of all outputs from the safety database supporting routine safety oversight activities, aggregate reports, ad-hoc Health Authority request etc.
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Supports PTC’s PV strategic business continuity plan.
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Authors ICSR-related processes and assists with the development, implementation and on-going enhancement of related SOPs.
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Maintains and archives manual and electronic drug safety files pertaining to ICSR management.
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Performs other tasks and assignments as needed and specified by management including line management
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Describe the following criteria, which are necessary to effectively perform the position:
- Minimum level of education and years of relevant work experience.
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BSN/RN, Bachelor’s degree in Biological Sciences, Pharmacy or PharmD degree preferred and a minimum of 7 years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 3 of which were spent in a leadership role within pharmacovigilance operations.
- Special knowledge or skills needed and/or licenses or certificates required.
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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.
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Extensive, hands-on working knowledge of MedDRA terminology and the processing of AEs/SAEs in the pharmaceutical industry.
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Demonstrated hands-on experience with Argus Safety database.
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Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality (e.g., SAE reporting throughput rate).
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Demonstrated ability to identify opportunities to improve the PV reporting process(es).
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Ability to influence without direct authority.
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Proficiency with Microsoft Office.
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Excellent verbal and written communication and skills.
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Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
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Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
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Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Special knowledge or skills and/or licenses or certificates preferred.
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Understanding of safety database administration, configuration, data entry and extraction.
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Expertise in the use of Electronic Document Management System (eDMS) software.
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Expertise in WHODD with relevance to coding suspect drug and concomitant medications.
0-10%
- Physical requirements (only note if the job requires physical capacity beyond general office work)
Office / Remote based position
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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