Pharmacovigilance Services Associate
Job Description
- Manage the Affiliate Mailbox and reconcile reports per process.
- Perform all written follow-up attempts for both Serious and Non-serious cases.
- Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database.
- Ensure compliance with client guidelines and applicable global regulatory requirements.
- Solve routine problems, largely through precedent and referral to general guidelines.
- Work as an individual contributor as a part of a team, with a predetermined, focused scope of work.
- Possess a Bachelor of Pharmacy or Master of Pharmacy qualification.
- Have 1 to 3 years of experience.
Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:1 to 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. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. 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.
What are we looking for? Looking for a Drug safety associate
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 own team and direct supervisor • You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments • The decisions that you make would impact your own work • You will be an individual contributor as a part of a team, with a predetermined, focused scope of work • Please note that this role may require you to work in rotational shifts
