PrimeVigilance: Advance Your Career in Pharmacovigilance and Drug Safety
About PrimeVigilance
PrimeVigilance is a leading global provider of pharmacovigilance and drug safety services. We are committed to ensuring the safety of patients and the integrity of pharmaceutical products worldwide. We foster a supportive, people-first work environment with opportunities for professional growth and development. We are currently seeking talented and motivated individuals to join our growing team in India.
Job Openings
We are pleased to announce the following open positions:
- Senior Benefit-Risk Associate (Pune)
- Senior Medical Writer (Bengaluru/Remote)
1. Senior Benefit-Risk Associate – Pune
Summary:
PrimeVigilance is seeking a skilled Senior Benefit-Risk Associate to join our team in Pune. In this role, you will be responsible for contributing to end-to-end signal detection activities, analyzing safety signals, and drafting high-quality detection reports. The ideal candidate will possess strong expertise in signal detection and management tools, coupled with a passion for patient safety.
Job Overview:
As a Senior Benefit-Risk Associate, you will play a critical role in ensuring the safety of our products and contributing to our mission of protecting patient health. Your responsibilities will encompass the entire signal detection process, from initial setup to final report generation. You will work collaboratively with cross-functional teams to ensure compliance with regulatory guidelines and internal procedures.
Key Responsibilities:
- Participate in the setup and execution of end-to-end signal detection activities.
- Review line listings to identify potential safety signals.
- Draft, edit, and quality-check complex signal detection reports.
- Evaluate and categorize potential safety signals based on their severity and frequency.
- Recommend appropriate regulatory actions based on signal evaluations.
- Support communication with regulatory authorities regarding safety concerns.
- Maintain comprehensive PV documentation and tracking systems.
- Collaborate with cross-functional departments to ensure procedural compliance and data consistency.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences or Biomedical Sciences (Pharmacy preferred).
- Prior experience in pharmacovigilance signal detection is required.
- Demonstrated understanding of signal management systems and tools.
- Excellent analytical ability with a keen attention to detail.
- Strong written and verbal communication skills, including English proficiency (B2+).
- A strong motivation and passion for patient safety.
Benefits:
- Opportunity for global exposure through collaboration with EU, US, and APAC teams.
- Strong emphasis on professional development and growth.
- Supportive and people-first work culture that values employee well-being.
- Comprehensive training programs and internal career mobility opportunities.
- Competitive salary and benefits package, promoting work-life balance.
Location: Pune, Maharashtra
Salary Range: ₹7,00,000 – ₹12,00,000 per annum
2. Senior Medical Writer (With Line Management Experience) – Bengaluru/Remote
Summary:
PrimeVigilance is seeking a Senior Medical Writer with strong experience in pharmacovigilance aggregate report writing and demonstrated team leadership abilities. The ideal candidate will be responsible for authoring and reviewing regulatory documents across the product lifecycle, including PBRERs, DSURs, and RMPs.
Job Overview:
As a Senior Medical Writer, you will be a key contributor to the creation and maintenance of high-quality regulatory documents essential for ensuring product safety and compliance. This role involves independent writing, editing, and reviewing of safety documents, as well as mentoring and managing Associate Medical Writers.
Key Responsibilities:
- Independently write, edit, and review regulatory and clinical safety documents, including PBRERs, DSURs, and RMPs.
- Ensure compliance with internal templates and regulatory standards.
- Participate in the development and maintenance of SOPs and quality documents.
- Support PV operations related to medical writing activities.
- Mentor and manage Associate Medical Writers, providing guidance and support.
- Maintain continuous self-learning in medical writing and PV guidelines.
Qualifications:
- Life Sciences degree or equivalent medical/nursing qualification.
- Significant experience in writing PBRERs, DSURs, RMPs, and other lifecycle safety documents.
- Proven line management or team leadership experience.
- Ability to handle multiple writing projects simultaneously and prioritize tasks effectively.
- Excellent command of the English language, both written and spoken.
Benefits:
- Competitive compensation package commensurate with experience.
- Opportunity for global cross-cultural collaboration and exposure.
- Extensive internal training programs to enhance skills and knowledge.
- Flexible/remote work option available.
- Growth-oriented organizational culture with opportunities for career advancement.
Location: Bengaluru (Remote option available)
Salary Range: ₹12,00,000 – ₹20,00,000 per annum