Urgent opening: Executive Safety Writer (1–2 years exp) at Fidelity Health Sciences, Andheri East. Hands-on role in PSUR, PBRER, RMP & ACO for Europe, UK & ROW markets. Excellent opportunity in pharmacovigilance jobs Mumbai and drug safety careers in India!
Contents
About the Company
Fidelity Health Sciences (FHS) is a reputed pharmacovigilance and regulatory service provider based in Mumbai, delivering high-quality drug safety, medical writing, and regulatory solutions to pharmaceutical and biotech companies worldwide.
With a strong focus on patient safety and regulatory compliance, Fidelity supports clients across Europe, UK, emerging markets (Ukraine, South Africa, Kazakhstan, etc.), and ROW regions.
The company is known for its scientific excellence, timely delivery, and audit-ready processes. Fidelity fosters a collaborative, learning-oriented culture with emphasis on guideline updates (GVP, ICH, MHRA) and employee development.
Its Andheri East office serves as a key hub for aggregate reporting and safety writing teams in India.
Job Details
- Company Name: Fidelity Health Sciences
- Experience: 1–2 years in Pharmacovigilance / Safety Writing
- Qualification: M.Pharm (Pharmacology / Pharmaceutics / Pharmacovigilance preferred)
- Location: Andheri East, Mumbai (On-site)
- Work Type: Full-time On-site
- Job Code: FHS/2025/INS/25
Job Description
Fidelity Health Sciences is looking for an Executive Safety Writer to join its growing Pharmacovigilance team in Andheri East, Mumbai. This role focuses on authoring and managing aggregate safety reports (PSUR, PBRER, RMP, ACO) for global submissions.
You will work on end-to-end report preparation, literature searches, data procurement, quality & medical reviews, and regulatory query resolution in a guideline-driven environment.
Executive Safety Writer
- Department: Pharmacovigilance / Drug Safety
- Role: Executive Safety Writer (Job Code: FHS/2025/INS/25)
- Experience: 1–2 years in aggregate reporting & safety writing
- Education/Qualification: M.Pharm
Skills/Qualifications
- 1–2 years hands-on experience in PSUR/PBRER/RMP/ACO drafting
- Strong knowledge of GVP, ICH, MHRA & regional guidelines
- Experience generating Line Listings from safety databases (Argus/ARISg preferred)
- Literature search & reference management skills
- Proficient in MS Office (Word, Excel, PowerPoint)
- Excellent scientific writing and communication skills
- Ability to meet strict timelines and handle audits/inspections
- Familiarity with sales data, RSI, study data procurement
Key Responsibilities
- Draft RMP, PSUR, PBRER & ACO for Europe, UK & ROW markets
- Generate Line Listings from safety database
- Procure sales, RSI, study & license data from internal teams
- Perform literature searches for safety information
- Compile & submit reports within regulatory timelines
- Address Quality Review & Medical Review comments
- Finalize reports post all reviews
- Support audits, inspections & SOP preparation
- Resolve regulatory authority queries
- Stay updated with evolving guidelines
Benefits/Perks
- Competitive salary & performance incentives
- Exposure to global submissions (Europe, UK, emerging markets)
- Structured training on latest guidelines & tools
- Career progression in pharmacovigilance & medical writing
- Supportive team & regular knowledge-sharing sessions
- Convenient Andheri East location with onsite facilities
- Opportunity to face audits & interact with regulators
How to Apply
Send your updated CV mentioning Job Code FHS/2025/INS/25 in the subject line to: hrrecruitment@fidelityhs.com
For more pharmacovigilance jobs, safety writer openings, and drug safety roles in Mumbai, visit Pharma Recruiter.
Apply now and take the next step in your aggregate reporting career with Fidelity Health Sciences!
Why You Should Join
Fidelity Health Sciences provides a dynamic platform to work on high-visibility global safety reports with direct impact on patient safety. The role offers rapid learning, mentorship from seniors, and exposure to diverse markets & guidelines.
Join a company that values quality, compliance, and professional growth while enjoying long-term stability in the booming pharmacovigilance sector in Mumbai.
FAQs
What experience is required for Executive Safety Writer at Fidelity?
1–2 years specifically in drafting PSUR, PBRER, RMP, ACO along with Line Listing generation and literature search.
Is M.Pharm mandatory for this Fidelity pharmacovigilance role?
Yes, M.Pharm is the required qualification. Candidates with relevant aggregate reporting experience will be preferred.
Will I get exposure to European & UK submissions?
Yes, the role involves regular drafting for Europe, UK MHRA, and ROW markets including Ukraine, South Africa, Kazakhstan, etc.
Is the position work-from-home or onsite?
Full-time onsite at Andheri East, Mumbai office.
