Medical Review Safety Physician - Manager

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Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Taguig, National Capital Region (Manila), Philippines

Job Description:

Essential Job Duties and Responsibilities 

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes single case signal detection activities for selected products.

 

The Medical Review Safety  Physician (MRSP), at the Manila site has primary responsibility for determining the medical and scientific relevance of 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. Additionally, SSPs participate in matrix management activities (e.g. Safety Management Team (SMT)) and provide pharmacovigilance expertise on individual case reports. MRSPs support activities such as evaluating safety issues from various sources including Designated Medical Events (DME) and Events of Interest (EVOI), preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data.

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes single case signal detection activities for selected products.

 

• Active participation in MRSP activities which include, but are not limited to:
  • Analysis and assessment of SUSARs
  • Analysis and assessment of Critical Cases
  • Detection of single case signals/ through validation
  • Member of Safety Management Team
  • Active participation in Signal Evaluation
  • Ensuring Follow-up of all critical case/ Events of Special Interest (RMPs identified risks)
  • PBRER activities
  • Investigator Brochure activities
  • Watchlist activities

 

• Identification and analysis of new safety signals and trends
• Review of Designated Medical Events (DMEs) and Event of Interests (EVOIs) for 

potential signals, from the  DME and EVOI assessments coming from vendors.

• Review of potential signals from local literature assessed by vendors and Local

Management Safety (LMS)

• Perform  validation of potential signals and coordinate with MSO.Prepare summary

analysis of safety data for the SMTs. Provide recommendations for further

evaluation.

 

• Participation in  pharmacovigilance matrix-teams (i.e. Safety Management Teams)

responsible for pharmacovigilance activities focused on products and therapeutic

areas as assigned.

 

• ·Support GMS Product Team to drive change, increase efficiency, effectiveness and quality, and foster alignment, across GMS and with key stakeholders.

 

 

Minimum Qualification

• Physician (MD or equivalent) with a medical degree from a recognized medical institution.
• A minimum of 1 year of clinical practice after postgraduate training program is preferred..
• A minimum of 3 years of experience in industry, academia or patient care settings is required.
• Direct experience in pharmacovigilance is strongly preferred.
• Experience and knowledge of Good Clinical Practices is required.

• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Fluent in written and spoken English.
• Working knowledge of the use of Microsoft suite of software products, including Excel and Word.

 

 

Required Skills:

 

 

Preferred Skills:

Clinical Operations, Compliance Management, Compliance Risk, Critical Thinking, Cross-Functional Collaboration, Medicines and Device Development and Regulation, Organizing, Quality Control (QC), Research Ethics, Risk Management, Risk Management Framework, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Tactical Planning, Team Management