Company Description
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world.
Job Description
POSITION SUMMARY
PV associate in literature must participate in Global Literature Screening process, by providing review and assessment of the scientific and medical literature, according to procedures and regulatory requirements.
CORE RESPONSIBILITIES
- · To participate in weekly and ad hoc literature searches
- · To participate in weekly and ad hoc literature screening activities to identify potential ICSRs and other relevant safety related information pertaining to nominated products for use in signal detection and aggregate reports, and document the process in literature screening tracker
- · To plan and conduct the review of literature references
- · To order copies of full literature articles for review
- · To order translation of literature reference if applicable
- · To forward any ICSRs for data entry into the global drug safety database in timely manner
- · To inform QCer that review is done
- · To participate in sensitivity testing
- · To monitor mailbox
- · To populate and maintain Literature Weekly Tracker in timely manner
- · To populate ACTi Time accurately and in timely manner
- · To check if all urgent/immediate issues have been addressed in a timely manner
- · To report to senior team members and unit head, and provide them with regular updates regarding project status and metrics concerning enquiries
- · Assisting in departmental regulatory inspection preparedness for the company PV system and actively participating in PV inspections or audits
SPECIFIED ADDITIONAL RESPONSIBILITIES
- · To participate in Regulatory Agency Screening
- · Accessing and tracking EV MLM search and MLM ICSR results
Qualifications
- Life science graduate, pharmacy, nursing, other healthcare related qualification
- 1-2 years of work experience in pharmacovigilance
- Organization skills, including attention to detail and multitasking · Ability to work in team
- To have time and issue management skills
- Japanese and English - advanced (spoken, written)
- Advanced MS Office, Teams and Excel skills
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
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