Area Safety/ Pharmacovigilance Specialist

Arbetsbeskrivning

As a consultant at Randstad Life Sciences, we are your employer, but you have your daily workplace at one of our customers. Your consultant manager is always close at hand, both during and between assignments, to help you develop your career in the direction you dream of.

As a consultant with us, you will receive a competitive salary, benefits and collectively agreed terms. We are responsive to your wishes regarding assignments and tasks and with our broad client portfolio in Mälardalen, we will together adapt your continued career according to your competence, experience and ambition.

At Randstad Life Sciences, we have an offer that means you have the opportunity to develop your skills and/or take extra leave after you have been with us for a while. You will be part of a larger consulting team within Life Sciences and have the opportunity to broaden your network and gain valuable experience from different workplaces.

Right now we have a 12 month assignment starting in June, with our customer in Solna.

Possibility of hybrid workplace 60%.

About the assignment:This position reports into Area Safety Officer and is based at Solna.

The 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.

Ansvarsområden

1- Act as Local Nominated Person (including back-up nominated person)

Function as nationally nominated person or back up for the local nominated person for Pharmacovigilance in respective countries assuming the PV role as defined by national law if applicable.

2- Safety and PV System Management

• Perform regulatory monitoring for impact on vigilance activities and responsibilities.

• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).

• Maintain oversight of proper identification of local literature articles for AE reporting as required.

• Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other departments as applicable.

• Receive and support the Area Safety lead in the responses to safety-related health authority queries in the territory.

• Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals.

• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances 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.

• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.

• Perform other agreed tasks assigned by manager

• Perform document management and archiving as required

• Perform training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.

3- Procedural Document

• Ensure current knowledge of all relevant company procedures and training.

• Develop, update, and implement local procedures to ensure compliance with company procedures and national requirements

4- Audit & Inspection readiness

Support in 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 (Corrective and Preventative Action) plans as applicable

5- PV contract management

Provide PV clauses to be included within local agreements

6- Business Continuity

Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage)

Kvalifikationer

Required Qualifications

• Education: health care science professional e.g.: (nurse, pharmacist, life science degree) or equivalent training and experience.

• 1-2 years of relevant experience.

• Pharmaceutical industry experience including product vigilance responsibility role.

• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.

Desired Qualifications

• Sound knowledge of medical terminology

• Computer literate.

• Good verbal and written communication skills

• Ability to establish and maintain open relationships within the organization and with authorities

• Fluency in the national language(s) and the English language.

*Key Responsibilities

Om företaget

Randstad

På Randstad vet vi att alla människor har en plats på arbetsmarknaden. Med verksamhet över hela landet och inom alla kompetensområden hjälper vi människor att hitta ett jobb som känns bra, och där de får möjlighet att växa, utvecklas och uppnå sin fulla potential.

Med närmare 600 000 anställda i 38 länder är Randstad världsledande inom HR-tjänster, med målsättningen att bli världens främsta och mest uppskattade partner på arbetsmarknaden. Genom att kombinera vår passion för människor med kraften i dagens teknologi hjälper vi människor och företag att uppnå deras fulla potential. Vi kallar det Human Forward.