Are you looking for a rewarding career in pharmacovigilance? Unichem Laboratories, one of India’s most respected pharmaceutical companies, is hiring for two exciting roles in Mumbai: Officer – PV Medical Writer and Compliance Officer – PV. With a legacy of innovation and a commitment to better health, Unichem Labs offers an incredible opportunity for professionals with 2-5 years of experience to join their team. Whether you’re skilled in medical writing or compliance management, these pharmacovigilance jobs in Mumbai could be your next big career move!
Why Unichem Laboratories is a Top Employer in Pharma
Unichem Laboratories, founded in 1944 by Padma Bhushan Amrut V Mody, is a pioneer in the Indian pharmaceutical industry. Headquartered in Mumbai, the company is known for its high-quality formulations and global presence in markets like the USA and Europe.
Right now, Unichem Labs is hiring for two pharmacovigilance positions in Mumbai, offering competitive salaries (not disclosed) and a chance to work in a dynamic environment.
Job 1: Officer – PV Medical Writer at Unichem Labs
Job Overview
- Position: Officer – PV Medical Writer
- Experience: 2-5 years
- Location: Mumbai (All Areas)
- Openings: 1
Responsibilities
As an Officer – PV Medical Writer, you’ll play a key role in ensuring drug safety through high-quality regulatory documentation. Here’s what you’ll be doing:
- Managing scheduled and unscheduled aggregate reports like PSURs, PBRERs, ACOs, PADERs, RMPs, and HHEs.
- Authoring, editing, and reviewing regulatory and clinical documents independently.
- Generating line listings, creating drug folders, and handling regulatory submissions.
- Developing literature search strategies for safety reports’ epidemiology sections.
- Ensuring data consistency, performing quality checks, and mentoring junior team members.
- Distributing final reports to health authorities and archiving source documents.
Desired Skills
To excel in this pharmacovigilance job, you’ll need:
- Expert knowledge of FDA, ICH GCP, GVP Modules, and EU Clinical Trial Directive.
- Proven experience in pharmacovigilance medical writing (e.g., PBRERs, PSURs, RMPs).
- Ability to multitask, prioritize, and pay attention to detail.
- Proficiency in document management systems and tools like Excel and Outlook.
- Strong mentoring and communication skills.
Job 2: Compliance Officer – PV at Unichem Labs
Job Overview
- Position: Compliance Officer – PV
- Experience: 2-5 years
- Location: Mumbai (All Areas)
- Openings: 1
Responsibilities
The Compliance Officer – PV ensures Unichem Labs meets all pharmacovigilance standards and regulations. Your key tasks will include:
- Ensuring compliance with SOPs and local, national, and international pharmacovigilance laws.
- Acting as a liaison during audits and regulatory inspections.
- Maintaining control documentation, including SOPs and training records.
- Conducting vendor and external audits as needed.
- Monitoring ICSRs and periodic reports (5% monthly sampling) for compliance.
- Identifying training needs and managing deviations.
Desired Skills
Here’s what Unichem Labs is looking for:
- Deep understanding of FDA, ICH GCP, GVP Modules, and global regulations.
- Strong organizational skills to handle multiple tasks and deadlines.
- Attention to detail and decision-making abilities.
- Familiarity with document management systems and Microsoft Office tools.
- Awareness of global regulatory reporting obligations.
