Job Description Summary: Under the oversight of the EU QPPV, the Associate Director, Pharmacovigilance (PV) LATAM fulfills the responsibilities associated with being a nominated safety contact to Regulatory agencies in South America where required and appropriate.
More specifically, the Associate Director PV LATAM is responsible for oversight of the pharmacovigilance system for all of PTC’s medicinal products in the LATAM region. This includes, but may not be limited to, ensuring that PTC has an appropriate pharmacovigilance system in place; conducting review(s) of the safety profile for marketed products and acting as the point of contact with the appropriate regulatory/competent authorities as required and appropriate.
The Associate Director PV LATAM will fulfil the role of QPPV in Brazil and nominated safety contact in other countries where required. Working with the EU QPPV, they will provide oversight for the quality and standards of the PV function in LATAM in order to ensure full compliance with LATAM PV regulations.
The incumbent works cross-functionally with internal departments and external resources on PV-related issues.
The Associate Director PV LATAM also supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Job Description:
- Fulfills all regulated responsibilities of the Brazilian Qualified Person for Pharmacovigilance.
- As per PV regulations in the LATAM region, acts as the single PV contact point for the LATAM regulatory authorities and is also as a contact point for PV inspections.
- Ensures PTC PV is in full compliance with LATAM PV legislation, regulations, and guidance.
- Reviews and approve PV documents to be submitted within the region as per local regulations e.g. country specific addendums to Risk Management Plans (RMPs)
- Oversees and supports all nominated safety contacts in the region in by maintaining an open line of communication and through quarterly meetings.
- Supports market expansion in LATAM and collaborates with local operating company’s key stakeholders.
- Key contributor to the company’s adherence to the PV quality system, SOPs and processes. Ensures compliance with PV-related regulations within the region.
- Responsible for the authoring and delivery of region-specific PV documents required per local regulations.
- Maintains awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products and maintains awareness of risk minimization measures.
- Supports timely submission of expedited ICSRs and safety reports to concerned local health authorities (where applicable).
- Ensures quality, including the correctness and completeness of PV data submitted to the competent authorities in Members States and the Agency.
- Provides input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).
- Working with the EU QPPV and Director PV Agreements contributes to Safety Data Exchange Agreements (SDEAs) and/or PV agreements with PTC partners and/or vendors for LATAM specific obligations for safety data exchange and reporting.
- Builds relationships, and collaborates with, the Quality department to ensure appropriate processes are in place for inspection readiness. This includes, but may not be limited to, leading pharmacovigilance audit responses, developing and managing corrective action plans, etc.
- Contributes to inspection readiness and leads EU LATAM Authority inspections of PTC’s PV function.
- Participates in process improvement and vendor-client Safety Management Plans and timelines processing and reporting safety data from clinical trials and post-marketing surveillance within the LATAM region.
- Trains PTC stakeholders on LATAM PV regulations and requirements as required.
- Performs other tasks and assignments as needed and specified by management.
Minimum level of education and years of relevant work experience:
- Science, Nursing or Pharmacy degree required and a minimum of 7 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment as an LATAM PV contact.
Special knowledge or skills needed and/or licenses or certificates required:
- Fluent in Portuguese, Spanish and English
- Expert knowledge of LATAM PV regulations and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
- Experience in writing SOPs and developing processes.
- Experience handling inspections and audits and CAPA.
- Critical thinking and decision-making skills.
- Experience leading and contributing to inspection readiness, Health Authority audits, standardization of safety reports, SDEA negotiations, vendor management, etc.
- Demonstrated, hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
- 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 And/or Licenses Or Certificates Preferred.
- Ability to influence without direct authority.
Travel Requirements: 0-10%
Office based position
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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