HireDiversity

Singapore, SG

ASSOCIATE DIRECTOR, PHARMACOVIGILANCE PHYSICIAN-7724121120

Description

ASSOCIATE DIRECTOR

PHARMACOVIGILANCE PHYSICIAN

Janssen

Asia Pacific

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

DESCRIPTION:

The AD Pharmacovigilance Physician is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process. The AD Pharmacovigilance Physician (PVP) has primary responsibility for determining the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.

This medical expertise will be reflected in activities such as determining key events of interest, emerging safety issues identified from important individual case safety reports, assigning appropriate dictionary terms during coding and performing causality assessments for the purpose of determining international regulatory reporting requirements.

This position reports directly to the Director, Single Case Safety Analysis, PV Physician

RESPONSIBILITIES:

- Medical evaluation of adverse event reports, including but not limited to all serious and expedited reports and all pregnancy reports.
- Preparation of IND letters to investigators (SUA summaries).
- Provide medical guidance and opinions to drug safety associates, other GMS physicians and scientific staff in the evaluation and follow-up of individual case safety reports. Provide medical input for ad-hoc queries as requested.
- Participate in signal detection efforts, e.g. strategy meetings for PSURs and periodic reports and structured surveillance programs and other medical/scientific meetings.
- Review aggregate reports such US Periodic Reviews and non-serious line listings of events on a weekly basis to assess correct seriousness classification
- Oversight of pharmacovigilance physician activities at vendor sites.
- The PVP evaluates each adverse event report for seriousness, labelledness, corrects coding of the adverse event and ensures that all medically relevant information from the source documents are included in the MedWatch/CIOMS report. When necessary, the PVP requests the Safety associate to inquire for additional relevant information, per SOP and will discuss cases of particular interest with the PV Physician Team Lead, Global Medical Safety Medical Safety Assessment Physician, and/or safety surveillance physician.
- The PVP, in collaboration with the project physician, prepares a SUA summary (letter to the investigator) for serious, unlisted, associated adverse events occurring in specified IND trials.
- In performing these activities, the PVP is responsible for following international pharmacovigilance regulations, company and department SOPs and department and function working practices

This is not an exhaustive, comprehensive listing of job functions. May need to perform other duties as assigned.

Qualifications


REQUIRED:

- Medical degree from recognized university and Board Certified/Board Eligible or equivalent preferred. Or 2 years post-graduate training or combination of 5 years post-graduate training in a recognized medical specialty plus clinical medical experience acceptable.
- An unrestricted medical license or equivalent or eligibility in one of the GMS operational regions required.
- Familiarity with pharmaceutical industry principles of drug development and pharmacovigilance is preferred but not required.
- Sound knowledge of general medicine and clinical practice, and the ability to assess the clinical relevance of medical data and to interpret its clinical meeting is essential.
- Good communication skills (written and verbal) and the ability to work in a team-oriented, matrix environment is necessary

LOCATION

This position is to be based in Singapore. No relocation support will be provided.

HOW TO APPLY

Please follow the instructions below and apply using REQ 7724121120 by 7 JANUARY 2013. All applicants must come through the portal.

For External Applicants:

- Please visit the J&J Career site via www.careers.jnj.com
- Look for the position: ASSOCIATE DIRECTOR, PHARMACOVIGILANCE PHYSICIAN (Requisition ID 7724121120)
- Click I Accept in the Privacy Agreement.
- For first-time users: click on New User - create a username and password on the next page.
- For returning applicants: enter your Email Address and password.
- Follow the succeeding steps to create a profile and apply for the position.

Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Drug & Product Safety Science