Urgent Opening For Safety Surveillance
- Career Choice Solution
- 2 to 5 Yrs
- Multi-City, India
- 4 years ago
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Job Description
Roles and Responsibilities:
- To ensure compliance with global and local procedural documents and local implementation of
- Client Patient Safety objectives, policies, procedures and processes.
- To assist physician in maintaining up to date knowledge of the client products assigned with focus
- on the safety perspective. This includes but is not limited to pharmacology, indications, safety
- and efficacy aspects and could potentially include clinical studies and epidemiological analyses.
- To review clients surveillance strategy document and provide written confirmation verifying its
- understanding of changes.
- To review aggregate case reports from Client designated safety database using relevant IS
- systems.
- To review and assess literature bulletins and published meeting abstracts in accordance with
- businesss search strategy, using relevant IS systems.
- To identify safety signals from routine review of cumulative safety data and conduct initial
- evaluation of those signals and document outcome according to client specified criteria and
- requirements.
- To document potential signal and related information in the signal tracking tool and maintain
- surveillance action log up to date.
- To notify business surveillance team of any safety signal that it has detected that may require
- urgent evaluation and action.
- To prepare, summarize, evaluate and document routine pre-SERM (Safety Evaluation Review
- Meeting) safety outputs from business dedicated safety database, dedicated external databases
- (FDA AERS, WHO Vigibase) and the published literature.
- To participate in routine and ad-hoc team and project related meetings between Business and
- Handover Meeting, Surveillance Meeting, and Safety Management Team Meeting.
- To prepare training material, conduct and assess periodic and need based trainings as and when required.
- To provide ongoing training on the updated surveillance strategy document, routine signal
- management requirements, product safety profiles and updated safety signal detection criteria for new hires.
- To participate in conducting gap analysis, and identify the remedial actions for the improvement
- of quality of deliverables as and when required.
- To provide regular work update to lead-safety surveillance.
Requirement:
Academic and Professional Qualification:
Healthcare professional (B.Pharm, M. Pharm, PhD, Life sciences Post-graduate) with 2-5
years of Pharmacovigilance experience in Pharmaceutical Company or Contract Research
Organization (CRO) including safety surveillance or signal detection activities.
High level of medical competence, with an ability to balance this with industry standards
to achieve business goals.
Experience:
Knowledge of drug safety & clinical development and ICH/GCP principles
Good knowledge of pharmacovigilance practices, particularly in relation to signal
detection and evaluation.
Good knowledge of global Pharmacovigilance regulatory requirements.
Excellent written and verbal communication skills and ability to present and critically
discuss clinical data in both internal and external discussions with client.
Ability to evaluate, interpret and synthesize scientific data (analytical thinking).
Skills required:
Computer Literate ( good knowledge of MS Office)
Good working knowledge of safety database
Sound understanding of the Drug Safety and Regulatory process.
Good problem solving and decision making skills.
Others:
Capability to lead by motivation and example.
Ability to prioritize and organize.
Attention to detail.
Excellent interpersonal and communication skills.
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Bio Tech / R&D / Scientist
Functional Area: Not Applicable
Role/Responsibilies: Urgent Opening For Safety Surveillance
Contact Details:
Company: Career Choice SolutionLocation(s): Multi-City, India
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