Accenture Drug Safety Surveillance Associate Vacancy – Apply Online
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Job Title: Drug Safety Associate
JOB NO. 174567
Skill required: Pharmacovigilance – Pharmacovigilance and Drug Safety Surveillance
Eligibility Criteria: Bachelor of Pharmacy
Years of Experience: 1-3 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 an 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 as Protocols and amendments, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, and Safety Narratives, and Clinical Overview/abbreviated Clinical Overview.
- In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
- Adaptable and flexible
- Problem-solving skills
- Detail orientation
- Ability to establish a strong client relationship
- Agility for quick learning
Roles and Responsibilities
- In this role, you are required to solve routine problems, largely through precedent and referral to general guidelines
- Your expected interactions are within your team and direct supervisor
- You will be provided detailed to a moderate level of instruction on daily work tasks and detailed instruction on new assignments and the decisions that you make that would impact your work
- You will need to be well versed with basic statistics and terms involved in the day to day business and use it while discussing with stakeholders
- You will be required to help in the overall team’s workload by managing your deliverables and help the team when required
- You will be an individual contributor as a part of a team, with a predetermined focused scope of work.
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