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Job Title: Senior Drug Safety Associate
Experience: 7 to 11 years Qualification: M.Pharm, B.Pharm, B.Sc
Location: Bengaluru Industry Type: Pharma / Healthcare / Clinical research
Functional Area: Pharmacovigilance & Drug Safety Surveillance
End Date: 20th June, 2023
Job Description: As a Senior Drug Safety Associate, you will be responsible for ensuring the quality and accuracy of drug safety processes and procedures. Your main responsibilities will include:
- Implementing quality checks at various stages of the service execution to ensure high-quality services are delivered to the client.
- Reviewing the overall quality of Individual Case Safety Reports (ICSRs), including assessing the completeness and accuracy of information and the appropriateness of causality assessment.
- Conducting random sampling of locked cases from the previous day and reviewing them within agreed timelines for quality review purposes.
- Documenting identified errors and conducting root cause analysis.
- Communicating any potential errors observed during the quality check to the individuals involved in the processing of the case via email.
- Mentoring and training new hires or other associates.
- Being open to receiving training and transitioning across roles as per business requirements.
- Supporting audits and inspections and developing corrective/preventive action plans.
- Authoring process documents related to drug safety.
- Escalating issues or tasks that fall outside the normal scope of work.
Candidate Profile: To be successful in this role, you should have the following qualifications and skills:
- BSc/Bachelor of Pharmacy/Master of Pharmacy degree.
- Ability to work well in a team and demonstrate adaptability and flexibility.
- Quick learning agility and a commitment to quality.
- Attention to detail.
- Minimum of a Bachelor’s degree in Health Sciences; Bachelor’s Degree in Life Science with relevant Pharmacovigilance experience.
- Minimum of 2 years of experience in Pharmacovigilance, preferably with 3-6 months of experience with NVS Process, conventions, and products.
- Thorough knowledge of medical terminology, including familiarity with dictionaries like MedDRA and WHO-Drug.
- Good communication skills.
- Strong analytical ability.
- Proficiency in technology, including experience with MS Office and safety databases.
- Familiarity with automation technology relevant to the role.
- Strong proficiency in reading and writing English. Good proficiency in listening and speaking English.For more articles, Kindly Click here.
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