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1) Designation: Pharmacovigilance & Drug Safety Surveillance
- Qualification: B.Pharm, M.Pharm, B.Sc
- Total Experience: 07-11+years
- Department: Pharmacovigilance
- Location: Bengaluru
Skill required: Pharmacovigilance – Pharmacovigilance & Drug Safety Surveillance
Designation: Senior Drug Safety Scientist
Job Location: Bengaluru
Qualifications: BSc/Bachelor of Pharmacy/Master of Pharmacy
Years of Experience: 7 to 11 years
What would you do?
You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings – Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. You will be part of a dynamic Pharmacovigilance team with array of capabilities ranging from detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem following Good Pharmacovigilance Practice (GVP) per client SOPs and applicable global regulatory requirements (Individual Case Safety Reports) to working on various aspects of Aggregate reports such as planning, authoring, reviewing and publishing of PBRER, PSUR, DSUR, PADER, Addendum to clinical overview (AdCO), Risk Management Plan (RMP), Signal detection and validation reports (SDVR), Cosmetovigilance Safety Reports (CoSR). The Pharmacovigilance team is also responsible for authoring and reviewing clinical documents such Protocols and amendment, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, Clinical Overview/abbreviated Clinical Overview. Perform quality checks and related activities on approved ICSRs as per client specifications/ or approved score cards. Also provide training as per requirements and contribute toward deal compliance
What are we looking for?
Ability to work well in a team Adaptable and flexible Agility for quick learning Commitment to quality Detail orientation Educational and Experience Requirements: Minimum of Bachelor s degree in Health Sciences; Bachelor s Degree in Life Science with relevant Pharmacovigilance experience. A Minimum of 2 years of experience in Pharmacovigilance required; 3- 6 months of experience with NVS Process, conventions and products preferred. Thorough knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug Good Communication Skills Analytical Ability Technology skills: experience with MS office, knowledge of safety database Automation technology as applicable for the role Strong English Language proficiency (Reading and Writing) Good English Language proficiency (Listening and Speaking)
Roles and Responsibilities
Responsibilities/Authorities: Implement Quality Checks steps on all its processes and procedures during the execution of the Services in order to provide quality Services to Client. Review overall quality of the ICSR case, including the completeness of the information, accuracy of the data entered, and appropriateness of the causality assessment. focus on the locked cases from the previous daily, by taking random samples for Quality review. All the sampled cases should be reviewed within the agreed timelines. Document the detected errors and perform root cause analysis. communicate observations (potential errors) identified during quality check of the case to the individual involved in processing of case via email. To mentor and train new hires or other associates. Open to get trained and move across roles based on business requirement. Supports audits and inspections, develop corrective/preventive action plans Authoring of process documents Escalate issues or tasks outside the normal scope of work.
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