Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Senior Area/Local Safety Officer Consultant for 12 months Contract with possibility of extensionto join one of our clients.
Hybrid Model: 2-3 days a week
Language: The contractor must be fluent in English and have Spanish as a mother tongue.
Job Description
Senior Area Safety Officer, Local PV Spain and Southern Europe
This position reports into Area Safety Head and is based in Madrid, Spain
POSITION SUMMARY:The Senior Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/ procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners. This role might act as the LOC’s and assigned territories main point of contact for pharmacovigilance matters (including cosmetovigilance, materiovigilance and nutrivigilance) with the local health authority.
They will ensure that appropriate product vigilance and risk management systems are set in place to assure appropriate oversight of products within its responsibility.
PRINCIPAL RESPONSIBILITIES:
* Oversight of the PV System & Overall responsibilities
* Provide oversight of vendor resources within Spain, Andorra, Italy, San Marino, Vatican City, Portugal, Greece and Cyprus.
* Support the Area Safety Head in providing relevant local information for the European Economic Area Pharmacovigilance System Master File.
* Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).
* Safety Management & Reporting
* Receive and support the Area Safety Head in the responses to safety-related health authority queries.
* Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
* Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required.
* Perform document management and archiving as required.
* Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
* Perform regulatory monitoring for impact on vigilance activities and responsibilities.
* Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
* Manage reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other departments as applicable.
* Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetovigilance, materiovigilance and nutrivigilance, including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
* Ensure pharmacovigilance compliance of local company sponsored programs and research activities as applicable.
* Perform translation for ICSR and PV-related documents, as required.
* Provide technical and strategic input and participate in projects/ workstreams led by the Medical Safety teams or LOC.
* Procedural Document
* Develop, update, and implement local procedures to ensure compliance with global procedures and national requirements.
* Ensure current knowledge of all relevant company procedures and training.
* Audit & inspection readiness
* Support local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA plans as applicable.
* Vigilance contract management
* Management of vigilance contracts and clauses: set-up, revision, internal tracking and periodic reconciliations.
* Business Continuity
* Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).
Qualifications:
The minimum knowledge, skill, related experience, and ability requirements for the position.
Education:
Health care science professional e.g.: (Pharmacist, nurse…)
Years of Related Experience:
At minimum 3 years’ experience.
Knowledge, Skills, Abilities:
* Pharmaceutical industry experience including product vigilance responsibility role.
* Proven ability to organize workflow activities.
* Computer literate with knowledge of relevant IT safety systems.
* Good verbal and written communication skills.
* Ability to establish and maintain open relationships within the organization and with authorities.
* Demonstrable knowledge of local requirements and global aspects of product safety.
* Mother tongue: Spanish
* Fluency in the English language is required.
Key words: PSMF, PSSF,PV, Pharmacovigilance, Regional Lead
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I certify all information provided in this employment application is true and complete to the best of my knowledge and belief. I understand any false information or omission may disqualify me from further consideration for employment and may result in my dismissal if discovered at a later date.
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