Senior PV Physician

Position: Senior PV Physician I
Location: Turbigo

The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of IASRs 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 ICSS 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 ICSS/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 products life cycle. Serves on Clients advisory and scientific committees.
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
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 written)
Advanced literacy (MS Office)

Additional Information
Why Prime Vigilance
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

Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships

Come and join us in this exciting journey to make a positive impact in patients lives. We look forward to welcoming your application.
Remote Work
Yes

Employment Type

Full-time
Key Skills

EMR Systems
Post Residency Experience
Occupational Health Experience
Pain Management
SOAP
Primary Care Experience
Medical Management
Suturing
Workers' Compensation Law
Pharmacy Residency
Botox Experience
Epic

Experience:

years
Vacancy: 1
#J-18808-Ljbffr