Senior Pharmacovigilance Physician

**Company Description**
We are PrimeVigilance (part of Ergomed Group), 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.

The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of ICSRs, writing and/or reviewing signal detection reports, writing and or reviewing aggregate reports (DSURS, PSURS, PBRERs. PADERS), reviewing risk management reports (RMPs) and mentoring junior PV Physicians. The Senior PV Physician I is also expected to support the QPPV in medical aspects and safety issues as may be required by Company or Client.

**For the Client**
- To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment. Review includes 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. Including completion of all required supporting documentation such as trackers.
- 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.

Signalling

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

**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 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
**Qualifications**
- The PV Physician should be medically qualified as a physician
- 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, writte