Medical Reviewer Ii

4 months ago

Pune, 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.

**Job Description**:
The Medical Reviewer II is responsible for medical review of lCSRs and literature review, writing signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS/PBRERs/PADERS) as required by the Company or Client.
- To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse
- Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. Including completion of all required supporting documentation such as trackers.
- To review literature screening search strategy; review articles to determine if they contain ICSRs/SAEs related to the Medicinal Product or other safety related findings
- Reviewing database outputs
- To review and provide input in Periodic Safety Update Reports and Development Safety Update Reports
- Participating in signal detection activities including meetings and writing signal detection reports
- Evaluating and categorizing possible signals; Proposing a course of action whenever a possible signal is identified
- The Medical Reviewer II will support the Director of Projects as well as the QPPV, on a day to day basis as needed.

For the Company (This may include but is not limited to):

- Writing PV Procedures
- Mentoring less experienced Physicians

Physician Line Manager (as applicable):

- Distribution of tasks performed by physicians within designated team, as well as solving problems related to it on a daily basis - taking into account the quality of the work performed, respecting all relevant laws and procedures, as well as time limits
- Ensuring stimulating work atmosphere within the team - Developing and maintaining good relationship with clients
- Inform Medical Director about productivity and quality metrics of individual medics within medical team
- Mentoring and coaching of staff within the team.
- Cooperate with other Line Managers and Medical Director to continuously improve work processes

The above job description in no way states or implies these duties are the only duties performed by this employee. The employee is expected to perform other related duties necessary for the effective operation of the department and company.

**Qualifications**:

- The Medical Reviewer Level 2 should be medically qualified as a physician.
- Strong experience in pharmacovigilance is required.
- Excellent interpersonal skills.
- Ability to plan, organise, prioritise and execute multiple tasks. Ability to work effectively cross suturally and cross functionally and value the importance of teamwork.

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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