Pharmacovigilance Associate

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**Job Title**: Pharmacovigilance Associate

**Job Location: Trivandrum, India**

**Job Overview**:
The Pharmacovigilance Associate (PVA) primary responsibility is to assist with processing, reporting and filing of SAEs/AEs. This includes but is not limited to: retrieval of eCRF safety source data, review of source documents for identification and redaction of any protected information, SAE/AE data entry, upload of SAE/AE documentation to designated systems including the eTMF, maintenance of current project tracking, and assistance with safety reporting as requested. All activities will be in accordance with Caidya and/or client SOPs, ICH Guidelines and local regulatory requirements.

**Job Duties and Responsibilities**:

- Works under the supervision of PV Specialists and Team Lead
- Checks study mailboxes and retrieves SAE/AE-associated source data from eCRF system, as requested
- Reviews SAE/AE-associated source data for identification and redaction of any protected information
- Enters initial and follow up SAE information in the Caidya safety database or client’s database, according to project requirements, as required
- Uploads SAE/AE notifications, source documentation, acknowledgements, etc. to designated systems including Outlook mail folders, the safety database and the eTMF, as required
- May assist with pdf bundle creation containing SAE information for designated studies
- May assist with processing of requests to create CIOMS/MedWatch forms from TEMPO Safety
- Ensures project tracking is kept current and complete for designated projects
- Provides assistance with safety reporting, as requested
- May assist with follow-up of outstanding SAE/AE queries, as needed
- Other duties as assigned by Team Lead and/or PV Specialists

**Supervisory Responsibilities**: No supervisory responsibilities

**Job Requirements**:

- Education
- Healthcare or Life Science degree is a plus
- Experience
- Skills/Competencies
- Strong English language written and verbal communication skills
- Strong interpersonal skills
- Team-oriented and a strong team member
- Willingness for continuous on the job training and qualifications measures to ensure:

- Basic knowledge of Pharmacovigilance and good documentation practices
- Basic knowledge of ICH GCP and applicable regulatory requirements for assigned projects
- Proficient knowledge of eCRF and safety database systems used with assigned projects
- Ability to work with careful attention to details
- Highly organized
- Ability to work in a dynamic, changing environment
- Demonstrates honesty, trust, fairness, cooperation, self-control and flexibility
- Capabilities
- Will work from Corporate office location

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The company will not accept unsolicited resumes from third party vendors.