Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008.
We are proud to have achieved global organic growth year after year, with staff based across Europe, North America, and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
PrimeVigilance provides first-class support to our small to large pharmaceutical and biotechnology partners maintaining long-lasting relationships and becoming one of the global leaders in its fields.
We cover all therapy areas including medical devices.
We love investing in our staff by providing an excellent training and development platform.
We value employee experience, well-being, and mental health and we acknowledge that a healthy work-life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Job Description For the Client: To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment.
The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.
To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues.
To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy.
To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings.
To cooperate in the preparation of and provide input in Risk Management Plans.
Supporting the preparation of responses to regulatory authority requests.
Signalling.
Reviewing line listings.
Participating in signal detection activities including meetings, writing signal detection reports if applicable, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation.
Evaluating and categorizing possible signals and proposing a course of action.
Supporting preparation and review of benefit-risk reports.
Qualifications The PV Physician should be medically qualified as a physician.
Experience with ALS therapy area.
Previous experience in pharmacovigilance.
Ability to review different aggregate report types including PBRERs and DSURs.
Expertise in signal detection activities is essential.
Excellent interpersonal skills.
Ability to plan, organise, prioritise and execute multiple tasks.
Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork.
Communication skills.
Presentation skills.
English - advanced (spoken, written).
Advanced literacy (MS Office).
Additional Information Why PrimeVigilance 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 in 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 #J-18808-Ljbffr
