Hiring Freshers for Pharmacovigilance Associate

15 hours ago

Pune, India Crestenroll Technologies Full time

As a Pharmacovigilance Associate you are part of the Pharmacovigilance Department (sometimes called the Drug Safety Department). Your role is one of reporting adverse effects (AEs) and side effects, in accordance with the current Dutch and European legislation for pharmacovigilance. You may also train colleagues in departments such as marketing and sales, medical and clinical on how they need to comply with their reporting responsibilities for drug safety. For example, when reporting AEs it is necessary to determine what an Individual Case Safety Report (ICSR) is and establish whether the ‘four elements’ of an identifiable patient, an identifiable reporter, a drug and a side effect are present during the triage-phase of a report on possible side effects. You report to your company headquarters on clinical study-related AEs and SAEs and those arising from products already on the market and any other pharmacovigilance / product safety issues. A Pharmacovigilance Associate (PVA) role may also be called a Pharmacovigilance Officer, Drug Safety Officer (DSO), Drug Safety Associate, or a Patient Safety Specialist.

**Roles and Responsibilities**:

- ensuring the rapid and timely processing and managing of new and follow-up reports of adverse events (AEs) and side effects, as well as serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs);
- reporting AEs and side effects to the EMA, the Dutch authorities and - if these arise from clinical trials - to ethics committees and Drug Safety Management Boards (DSMBs), and steering committees of the respective clinical trials;
- processing all the AEs, SAEs and SUSARs in the Global Safety Database according to the applicable company policies and Standard Operating Procedures (SOPs), and as required by the Dutch and European Authority for reporting adverse events;
- contacting those who reported the AEs and side effects to obtain complete information for analysis;
- ensuring that assessments are carried out according to AE, SAE and SUSAR criteria and forwarding eventual AEs/SAEs and SUSARs to the head office;
- contributing to keep local processes, procedures and systems up to date and assisting with, and participating in, audits and inspections when these arise.

**Required Qualification**:
Bachelor’s degree in biological science or a related field. (B.Pharm/M.Pharm/ Pharm D/ MBBS/ BDS/ BAMS/ BHMS/ MD/ MDS BSc/MSc in Biotech, Chemistry, Botany, Zoology, Biochemistry, Microbiology)

**Required Skills**:
No work experience required

Strong verbal and written communication skills.

Proficient with Microsoft Office Word, Excel, and PowerPoint.

Ability to manage and prioritize workload effectively.

**Job Types**: Full-time, Fresher

**Salary**: ₹20,000.00 - ₹25,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Commuter assistance
- Flexible schedule
- Internet reimbursement
- Paid sick time
- Provident Fund
- Work from home

Schedule:

- Day shift
- Flexible shift
- Monday to Friday

Supplemental pay types:

- Performance bonus
- Shift allowance
- Yearly bonus

Ability to commute/relocate:

- Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

**Language**:

- English (preferred)

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