Principal Drug Safety Physician

2 weeks ago

Sahibzada Ajit Singh Nagar, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

Job Purpose:
Principal Safety Physician is responsible for performing medical & safety monitoring tasks in the assigned projects and contribute to medical review, analysis and guidance in all required safety reports. Principal Safety Physician is also responsible for providing medical leadership and subject-matter expertise to project teams, business development and pre-award activities.

Medical and scientific Pharmacovigilance review
> Provide medical review, analysis and guidance during the case handling
and reporting cycle of Adverse Event and Adverse Reaction reports
received for investigational and marketed products
> Analysis of Adverse Event Reports during ongoing surveillance and
signal detection, including independent analysis of safety risks
> Writing of safety section, including benefit risk assessment, of Periodic
Benefit-Risk Evaluation Report (PBRER)/ Periodic Safety Update
Reports (PSURs), Clinical Expert Statements and other documents as
required
> Provide support in preparation of aggregate reports like Periodic
Benefit-Risk Evaluation Report (PBRER)/ Periodic Safety Update Reports (PSURs)/Development Safety update Report (DSUR)/ Periodic Adverse Drug Experience Report (PADER/PAER)
> Review and sign off technical documents written by Parexel with respect
to medically relevant matters with attention to those relating to drug
safety
> Participate in Safety Signal and Risk Management activities including
review of Risk Management Plans (RMPs), Signal Evaluation Report
etc.
> Support Safety Review Committee activities

Provide medical guidance to PV team/study team
> Provide medical guidance to Safety Staff during the case processing
cycle
> Provide input as necessary to Feasibility Studies, Data Monitoring
Committees (DMCs), Clinical Endpoint Committees (CECs).
> Provide medical input into Pharmacovigilance workflows and projects as
required
> Provide medical safety expertise and training to other Parexel personnel,
as required

Medical monitoring
> Medical monitoring – answering day to day medical and scientific
questions, provide daily medical support to Parexel staff or site
(investigator/study coordinator)
> Review and sign off adverse events report for accuracy and clinical
importance, relationship to the study drug as well as for severity and
seriousness; provide sponsors with periodic experience reports
summarizing adverse events as required by the sponsor or authorities
> Attend and present material (such as therapeutic area training), as
requested, at internal and external meetings (such as investigator
meetings)
> Provide medical safety expertise to client per request
> Review and sign off Data Management line listings (including adverse
events, laboratory data, vital signs data, medical history, physical
examination, concomitant medication, efficacy end points), establish the
presence or absence of clinically meaningful trends and, if noted, follow
up as appropriate with the project team, sponsor, investigator, and
Regulatory Authorities
> Review and sign off technical documents written by Parexel with respect
to medically relevant matters with particular attention to those relating to
patient safety
> Review coding of adverse events and concomitant medications for
accuracy and consistency
> Review of patient profile report as needed
> Provide support for the preparation of clinical protocols, integrated
clinical and statistical summary reports, journal articles, and other
documents for clients/sponsors in conjunction with clients/sponsors or in
conjunction with other Parexel departments
> Attend and present material as requested, at internal and external
meetings (e.g. investigator meetings, therapeutic area training,
Regulatory Authority meetings)
> Be able to provide a 24 hours/day, 7 days/week availability per request

Provide medical and safety expertise to BD and marketing
> Participate in Proposal Development Teams (PDTs) for client bid
meetings
> Provide support for marketing activities as requested

Skills:
· Computer skills (MS Excel, power point, word etc.)
· Excellent presentation skills
· Excellent interpersonal skills
· Excellent verbal / written communication skills
· Excellent time management skills
· Client- and results-focused approach to work.
· A flexible attitude with respect to work assignments and new learning.
· Ability to manage multiple and varied tasks with enthusiasm whilst prioritizing workloads and
maintaining high attention to detail.
· Willingness to work in a matrix environment and value the importance of teamwork.

Knowledge and Experience:
> 4-5 Years relevant experience of medical review in PSUR/PBRER/Safety Science/Aggregate Reports/Signal
> Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
> Clinical Research (GCP) or Pharmacovigilance knowledge /qualifications
> Good knowledge of drug safety and the drug development process
> Considerable drug safety and/ or clinical trial knowledge and experience

Education :
· Medically qualified in an acknowledged Medical School with completion of at least a basic training in clinical medicine (residency, internship etc.)

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