Company Description
PrimeVigilance is a specialized mid-size pharmacovigilance service provider established in 2008, part of the Ergomed Group. We have achieved global organic growth year after year, with staff based across Europe, North America, and Asia, covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
We provide first-class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in our field. We cover all therapy areas, including medical devices.
We invest 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 nurtures an environment from which high-quality client service can be achieved.
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Job Description
The Senior Pharmacovigilance (PV) Physician II is responsible for medical review of ICSRs, writing and reviewing signal detection reports, writing and/or reviewing aggregate reports (DSURS, PSURS/PBRERs/PADERS, ACOs, responses to regulatory authority requests), writing and/or reviewing risk management reports (RMPs), and mentoring junior PV Physicians.
The Senior PV Physician II is also expected to support the QPPV in medical aspects and safety issues as may be required by the Company or Client.
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Responsibilities
* To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment, including coding, assessment of seriousness, listedness/expectedness, and Company causality, as well as writing of Company comment, follow-up questions, and Analysis of Similar Events, when required.
* To complete the adverse event tracker for all ICSRs reports.
* 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 approve 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/to lead the preparation of responses to regulatory authority requests.
* Can act as EEA QPPV and/or Deputy for up to 2 clients if required.
* To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, ACOs or Annual Safety Reports.
* To act as Company Lead in a specific pharmacovigilance area requiring medical input (e.g., for preparation of reference safety information – Company Core Data Sheet).
* Actively participate in the Drug Safety Review Committee - signal detection and risk evaluation process for Client company medicinal products in the product's life cycle.
* Serves on Client's advisory and scientific committees.
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Signalling
* Reviewing line listings.
* Participating in signal detection activities, including meetings, reviewing of signal detection reports, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation.
* Evaluating and categorizing possible signals.
* Proposing a course of action whenever a possible signal is identified.
* Supporting preparation and review of benefit-risk reports.
* Supporting PV Project Managers in the planning of signalling schedule and resources.
* Supporting PV Project Managers in the preparation of project-specific working instructions regarding signalling.
* Overseeing the quality of signal detection activities and providing quality and compliance metrics to the Quality Department.
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For the Company
* To support the preparation of PV procedures.
* To provide training and mentoring of junior PV Physicians.
* To provide medical advice and input to project teams on a daily basis.
* Training, mentoring, and managing junior PV Physicians.
* Continuously working on the development of the procedures on the company level.
* Preparing or contributing to the preparation of signalling-related company procedures.
* The Senior PV Physician will support the Director of Projects, as well as the QPPV, on a day-to-day basis as needed.
* Supporting the Medical Director in training and mentoring on signalling activities.
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Qualifications
* The PV Physician should be medically qualified as a physician with demonstrated experience in PharmacoVigilance and working in a clinical setting.
* Endocrinology experience is required.
* 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.
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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 in improving the lives of those around us.
* We offer:
o Training and career development opportunities internally.
o Strong emphasis on personal and professional growth.
o Friendly, supportive working environment.
o Opportunity to work with colleagues based all over the world, with English as the company language.
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* Quality.
* Integrity & Trust.
* Drive & Passion.
* Agility & Responsiveness.
* Belonging.
* Collaborative Partnerships.
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Come and join us in this exciting journey to make a positive impact in patient's lives. We look forward to welcoming your application