Pharmacovigilance Assistant

7 days ago

Mumbai, India PrimeVigilance Full time

Company Description

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

**Job Description**:
The PV Assistant will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. Previous work experience in pharmacovigilance is not required as you will receive all necessary training from us.

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them

**Responsibilities**:

- Receiving and returning safety messages and acknowledge receipt, tracking and filing of Individual Case Safety Reports (ICSRs) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
- Submitting and tracking periodic reports
- Maintaining the archive and preparing documents’ final lay out

**Qualifications**:
**Requirements**:

- University degree
- Advanced English skills, both verbal and written, at least B2
- Desirable administrative experience and good IT skills (MS Office)
- A high degree of discretion dealing with confidential information
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Ability to work under pressure with accuracy and meet tight deadlines
- Good interpersonal and communication skills

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

**We offer**:

- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships

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