Associate Pharmacovigilance - Freshers

ClinoGenesis Research Institute; Pune District; Remoto; INR 167.000 - 279.000; Tempo pieno

Vantaggi offerti da questo lavoro

Intensive onboarding & training

Comprehensive health benefits

Descrizione del lavoro

Clinogenesis Research Organization is hiring fresh graduates for an Associate Pharmacovigilance (PV) role. This entry-level position is remote and offers intensive training in global pharmacovigilance processes and safety data handling.

As a PV Associate you will process ICSRs, perform data entry, learn MedDRA coding, draft narratives, and ensure timely case processing under regulatory SOPs. Strong English communication and attention to detail are essential for success.

Competenze

• Bachelors/Masters in life sciences or pharma; freshers only.
• Mandatory Pharmacovigilance / Drug Safety certification.

Mansioni

• ICSR processing: review, log, and triage ICSR from trials, spontaneous reports, and literature.
• Data entry & triage: accurately enter adverse event data into global safety databases per SOPs.
• Medical coding: learn/apply MedDRA and WHO Drug dictionaries for coding events/medications.
• Narrative writing: draft clear, medically accurate case narratives of adverse events.
• Quality & compliance: ensure cases processed within regulatory timelines (FDA/EMA/CDSCO).

Conoscenze

English proficiency

Attention to detail

MS Office

Analytical thinking

Formazione

B.Sc./M.Sc./B.Pharm/M.Pharm/Pharm.D or Life Sciences

Descrizione del lavoro

Position: Associate Pharmacovigilance (PV)

Company: Clinogenesis Research Organization

Location: Remote

Job Type: Full-time, Entry-Level

Experience Required: 0 years (Freshers Only)

About Us

At Clinogenesis Research Organization, we are dedicated to advancing global healthcare through excellence in clinical research, drug safety, and data management. We pride ourselves on nurturing raw talent and providing a launching pad for the next generation of life sciences professionals.

We are expanding our Drug Safety team and are looking for enthusiastic, detail-oriented Freshers to join us as Pharmacovigilance Associates.

What You Will Do (Key Responsibilities)

• ICSR Processing: Review, log, and triage Individual Case Safety Reports (ICSRs) originating from clinical trials, spontaneous reports, and medical literature.
• Data Entry & Triage: Accurately enter adverse event data into global safety databases following strict standard operating procedures (SOPs).
• Medical Coding: Learn and apply MedDRA (Medical Dictionary for Regulatory Activities) and WHO Drug dictionaries for coding adverse events and medications.
• Narrative Writing: Draft clear, concise, and medically accurate case narratives explaining the chronological sequence of adverse events.
• Quality & Compliance: Ensure all cases are processed within strict regulatory timelines mandated by global authorities (FDA, EMA, CDSCO).

Who We Are Looking For (Eligibility Criteria)

• Education: B.Sc. / M.Sc. / B.Pharm / M.Pharm / Pharm.D or any graduate in Life Sciences (Biotechnology, Microbiology, Biochemistry, Zoology, etc.).
• Graduation Year: 2024, 2025, or 2026 pass-outs with all marks cards cleared.
• Certification: Mandatory certification in Pharmacovigilance / Drug Safety / MedDRA coding

Skills Needed

• Strong understanding of basic human anatomy, physiology, and pharmacology.
• Excellent written and verbal communication skills in English (crucial for narrative writing).
• High attention to detail and strong analytical thinking.
• Basic proficiency in MS Office (Word, Excel).

What’s In It For You?

• World-Class Training: Intensive onboarding program covering global PV regulations, database handling, and medical narrative writing.
• Career Growth: Rapid advancement pathways into Senior PV, Quality Reviewer, or Team Lead roles.
• Culture: A collaborative, supportive, and learning-driven work environment.
• Compensation: Competitive fresher stipend/salary with comprehensive health benefits.

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