Pharmacovigilance Job Opportunity at Fortrea | Pharmacy Fresh Graduates Apply Now
If you are searching for a Pharmacovigilance Job in the drug safety domain, this Pharma Job opportunity for a Safety Science Analyst could be the perfect start to your career. This role involves working with clinical safety operations, adverse event processing, and regulatory compliance within the pharmaceutical industry. Candidates with pharmacy and healthcare backgrounds can gain valuable experience in pharmacovigilance systems, safety reporting, and global regulatory requirements through this Pharmacovigilance Job in Pune.
- Job Title: Safety Science Analyst (6 Month Contract – Pune – HCP only)
- Location: Pune
- Job Requisition ID: 26902
About the Company
Fortrea is a global contract research organization providing clinical development and commercialization services to pharmaceutical, biotechnology, and medical device companies. The company supports clinical trials, regulatory compliance, and pharmacovigilance operations while maintaining high standards of safety and quality in drug development, offering Pharma jobs.
Job Description
Assist with the overall Clinical Safety and/or PSS operations associated with products, including the entire adverse events process, which may include safety data collected from clinical trials and/or post-marketing settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and/or the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as a stand-alone business. Responsible for providing all clients, both internal and external, with the appropriate quality of service safely and cost-effectively. The role will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989, and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
Key Responsibilities
- Perform case intake and triage of the incoming safety information or reports from various sources, either spontaneously or from a clinical trial.
Assist with processing of the adverse events, including but not limited to:
- Data entry of safety data onto adverse event tracking systems, Ideal for a Pharma job.
- Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable).
- Assist in the listing assessment against the appropriate label (for Marketed products, if applicable).
- Assist in the generation of queries and the collection of missing or discrepant information in consultation with medical staff, if needed.
- Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.
- Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel, etc.), and prioritize the reports for processing and submission within the regulatory and/or study-specific applicable timelines.
- Assist in the reconciliation of databases, as applicable.
- Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs), etc., as appropriate.
- Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable.
- Support upload/archival of case/study/project documentation, as appropriate.
- Build and maintain good PSS relationships across functional units.
- Support compliance of operations with governing regulatory requirements.
- All other duties as needed or assigned.
Qualifications
- Only B Pharm, M Pharm, Pharm D, BAMS, BDS, BHMS, and Nursing degree holders can apply
- Degree with 0-1 year of Safety experience or relevant experience
Experience
- Attention to detail.
- Team player.
- Solid written and verbal communication skills.
- Accurate math and spelling skills, preferably with an aptitude for handling and proofreading numerical data.
- Knowledge of MS Office Windows applications beneficial.
- Ability to operate standard office equipment.
